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Guidance Documents

Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.  Another method of obtaining guidance documents is through the Division of Drug Information.

 Newly Added Guidance Documents Guidance Documents will be retained in this section of the page for a period of three months.  The most recently added appears first and they are in the order of the date they were issued.

* Note: Draft guidances are undergoing finalization. Please contact the relevant division for the most up-to-date Agency perspective on an issue. For information on how to electronically submit a comment on a draft guidance, please see http://www.fda.gov/opacom/backgrounders/voice.html

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Guidances Arranged by Subject


Information About Guidances


Newly Added Guidance Documents:
Guidance Documents will be retained on this list for a period of three months. After three months you will find them under their specific "subject" on this page.  The most recently added guidances appears first and they are in the order of the date they were issued.

Title and Format Subject Type Issue Date

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF]

  • Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF]
International Conference on Harmonisation -Quality Final 2/20/2008
Safety Testing of Drug Metabolites [PDF] or [HTML] Pharm/Tox Final 2/14/2008
Acute Bacterial Otitis Media: Developing Drugs for Treatment [PDF] or [HTML] Clinical/Antimicrobial Draft
note*
1/17/2008
Q8(R1) Pharmaceutical Development Revision 1 [PDF] International Conference on Harmonisation -Quality Draft
note*
1/10/2008
Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act [PDF] Clinical/Medical Draft
note*
12/21/2007

Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)

Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter [PDF]

Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter [PDF]

International Conference on Harmonisation -Quality Draft
note*
12/14/2007

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Advertising

Title and Format Type Issue Date
Accelerated Approval Products: Submission of Promotional Materials  [PDF] Draft
note*
3/26/1999
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling  [PDF] Final 12/1997
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements [HTML] [PDF]
  • Labeling Example [PDF]
  • Labeling Example; Consumer-Friendly Version [PDF]
Draft
note*

2/4/2004
Consumer-Directed Broadcast Advertisements [HTML] or [PDF] Questions and Answers (Posted 8/6/1999) Final 8/1999
Consumer-Directed Broadcast Advertising of Restricted Devices [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
1/26/2004
“Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
1/26/2004
Industry-Supported Scientific and Educational Activities [HTML] or [PDF Final 12/3/1997
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling  [PDF] Draft
note*
1/1999

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Biopharmaceutics

Title and Format Type Issue Date
Bioanalytical Method Validation [HTML] or [PDF] Final 5/2001
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action [PDF]
Federal Register Notice [ TXT ] [ PDF ]
  • Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data   [PDF]
Draft
note*
4/2/2003
4/11/2003
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations [HTML] or [PDF] Final 3/2003
Cholestyramine Powder in Vitro Bioequivalence [PDF] (Intermin Guidance)  Final 7/15/93
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing [HTML] or [PDF] Final 6/17/2005
Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence. Draft
note*
Withdrawn
FR Notice
8/12/2005
Corticosteroids, Dermatologic (topical) In Vivo [PDF] (Issued 6/2/1995, Posted 3/6/1998) Final 6/2/1995
Dissolution Testing of Immediate Release Solid Oral Dosage Forms [PDF] (Issued 8/1997, Posted 8/25/1997) Final 8/1997
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations  [PDF] Final 9/1997
Food-Effect Bioavailability and Fed Bioequivalence Studies [HTML] or [PDF] Final 12/2002
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro
[PDF]
Final 6/27/1989
Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing   [PDF] Final 6/6/1994
Statistical Approaches to Establishing Bioequivalence [HTML] or [PDF] Final 2/2001
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.  [HTML] or PDF. Final 8/2000

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 [CGMPs] Current Good Manufacturing Practice (Pharmaceutical CGMPs for the 21st Century) / Compliance

Title and Format Type Issue Date
Bar Code Label Requirements--Questions and Answers [PDF]
Federal Register Notice [TXT] [PDF]
Final 10/5/2006

Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information  [PDF
Federal Register Notice [TXT] [PDF]

Draft
note*
9/3/2003
Compressed Medical Gases Final 2/1989
Computerized Systems Used in Clinical Trials [HTML] or  [PDF] Final 5/10/2007

Current Good Manufacturing Practice for Combination Products [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
9/29/2004
Current Good Manufacturing Practice for Medical Gases [PDF] Federal Register Notice [ TXT ] [ PDF ] Draft
note*
5/6/2003
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron  [PDF] Final 6/27/1997
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide [HTML] or [PDF]
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*
5/27/2005
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP [HTML] or [PDF] Final 1/11/2006
General Principles of Process Validation Final 5/1987
Good Laboratory Practice Regulations Questions and Answers [PDF] Final  3/2/1998
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory  [HTML] or [PDF] Final 4/5/2001
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24) Draft released for comment 
Federal Register Notice
Draft
note*
8/29/2006
Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices  [PDF] Final Posted 3/2/1998

INDs--Approaches to Complying with CGMP's for Phase 1 Drugs [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
1/12/2006
Investigating Out-of-Specification Test Results for Pharmaceutical Production [PDF] or [HTML] Final 10/11/2006
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients[PDF Draft
note*
4/17/1998
Marketed Unapproved Drugs -- Compliance Policy Guide [HTML] or [PDF] Final 6/8/2006
Monitoring of Clinical Investigations  [PDF] Final Posted 3/2/1998
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment  [PDF] Final Posted 3/2/1998
Part 11, Electronic Records; Electronic Signatures — Scope and Application [HTML] [PDF] Final 9/3/2003
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance [HTML] [PDF] Final 9/29/2004
PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML] or [PDF] Draft
note*
9/15/2005
Pharmacy Compounding -- Compliance Policy Guide  [PDF] Final 5/2002
Possible Dioxin/PCB Contamination of Drug and Biological Products [HTML] or [PDF] Final 8/23/1999
Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment [HTML]  [PDF]
Federal Register Notice [TXT] [PDF]
  • Revised Attachments [PDF]
Draft
note*
11/2003

Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics [HTML] or [PDF]

  • Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers [PDF] (Issued and Posted 11/13/2006)
Final  3/2006

Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Final 9/27/2006
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs Final 8/4/2004
Review of FDA's Implementation of the Drug Export Amendments of 1986  [PDF] Final 11/1989
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [HTML] [PDF] Final  9/29/2004
Street Drug Alternatives [HTML] or [PDF] Final  3/2000
Testing of Glycerin for Diethylene Glycol [ HTML] or [PDF] Final 5/1/2007
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP) [PDF] or [HTML] Draft
note*
10/18/2007

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Chemistry

Title and Format Type Issue Date

Analytical Procedures and Methods Validation. Optional format: PDF.
Federal Register Notice [TXT] [PDF]

Draft
note*
8/2000
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation 2/2001 Final Withdrawn as per FR notice June 1, 2006
Botanical Drug Products [HTML] or [PDF] Final 6/2004
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products  [PDF] Final 7/1997
Changes to an Approved NDA or ANDA [HTML] or [PDF] Final 4/2004
Changes to an Approved NDA or ANDA: Questions and Answers [HTML] or [PDF] Final 1/2001
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes [HTML] or [PDF] Final 11/19/2004

Comparability Protocols -- Chemistry, Manufacturing, and Controls Information [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
2/2003
Container Closure Systems for Packaging Human Drugs and Biologics [HTML] or [PDF]
  • Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers [PDF]
Final 5/1999
5/2002
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Final 4/1996
Development of New Stereoisomeric Drugs Final 5/1/1992
Drug Master Files
      Current DMF Information (e.g. lists, addresses, guidances, etc.)
Final 9/1/1989
Drug Master Files for Bulk Antibiotic Drug Substances [HTML] or [PDF] Final 11/1999
Drug Product: Chemistry, Manufacturing, and Controls Information   1/2003 Draft
note*
Withdrawn as per FR notice June 1, 2006
Drug Substance: Chemistry, Manufacturing, and Controls Information 1/2004 Draft
note*
Withdrawn as per FR notice June 1, 2006
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals  [PDF] Draft
note*
9/11/2003
Environmental Assessment of Human Drug and Biologics Applications [PDF] Final 7/1998
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* 2/1987 Final Withdrawn as per FR notice June 1, 2006
Format and Content for the CMC Section of an Annual Report   [PDF] Final 9/1/1994
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information [HTML] or [PDF] Final 5/20/2003
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information [HTML] or [PDF] Final 5/2001

Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]   

Draft
note*
7/24/1999

Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
7/2002
Monoclonal Antibodies Used as Reagents in Drug Manufacturing [HTML] or [PDF] Final 3/2001
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products [HTML] or [PDF] Draft
note*
11/13/1998
Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML] or [PDF] Final 7/2002
NDAs: Impurities in Drug Substances [HTML] or [PDF] Final 2/2000
Orally Disintegrating Tablets [HTML] or [PDF] Draft
note*
4/6/2007
PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites  [PDF] Final 4/28/1998
Reviewer Guidance, Validation of Chromatographic Methods  [PDF]
(revised to include graphics, 5/14/2007)
Final 11/1994
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) Final 12/20/2000
Stability Testing of Drug Substances and Drug Products   6/5/1998 Draft
note*
Withdrawn as per FR notice June 1, 2006
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products [PDF] Final 11/1994
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances 11/1994 Final Withdrawn as per FR notice June 1, 2006
Submitting Documentation for the Manufacturing of and Controls for Drug Products* [HTML] or [PDF] Final 2/1987
Submitting Documentation for the Stability of Human Drugs and Biologics*  (Issued , Posted 3/2/1998) Final Withdrawn as per FR notice June 1, 2006
Submitting Samples and Analytical Data for Methods Validation Final 2/1987
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances  [PDF] Final 2/1987
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation [PDF] Final 11/1995
SUPAC-IR Questions and Answers about SUPAC-IR Guidance Final 2/18/1997
SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum  [PDF] Final  1/1999
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation  [PDF] Final Issued 10/6/1997
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum  [PDF] Draft
note*
12/1998
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation  [PDF] Final 5/1997

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Clinical Antimicrobial

Title and Format Type Issue Date
Acute Bacterial Exacerbation of Chronic Bronchitis — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998
Acute Bacterial Meningitis — Developing Antimicrobial Drugs for Treatment [PDF] Draft
note*
7/22/1998
Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
10/29/2007
Acute or Chronic Bacterial Prostatitis — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998
Acute Bacterial Otitis Media: Developing Drugs for Treatment [PDF] or [HTML] Draft
note*
1/17/2008
Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval [PDF] or [HTML] Draft
note*
10/12/2007
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency [PDF] or [HTML]
  • Guidance for Submitting HIV Resistance Data [HTML] or [PDF]
  • Guidance for Submitting Influenza Resistance Data [HTML] or [PDF]
  • Guidance for Submitting HBV Resistance Data [HTML] or [PDF]
  • Guidance for Submitting HCV Resistance Data [HTML] or [PDF]
Final 6/2/2006
Antiretroviral Drugs Using Plasma HIV RNA Measurements — Clinical Considerations for Accelerated and Traditional Approval [HTML] or [PDF] Final 10/2002
Bacterial Vaginosis — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998

Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs for Treatment [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]

Draft
note*
10/1999
Clinical Development and Labeling of Anti-Infective Drug Products [HTML] or [PDF] Final 10/1992 Revised 2/12/2001
Clinical Evaluation of Anti-Infective Drugs (Systemic) [PDF] Final  9/77
Community-Acquired Pneumonia — Developing Antimicrobial Drugs for Treatment [PDF] Draft
note*
7/22/1998
Complicated Urinary Tract Infections and Pyelonephritis — Developing Antimicrobial Drugs for Treatment [HTML] or [PDF] Draft
note*
7/22/1998
Developing Antimicrobial Drugs — General Considerations for Clinical Trials [PDF] [Main Document] Draft
note*
7/22/1998

Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure) --   [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
3/15/2002
Empiric Therapy of Febrile Neutropenia — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998
Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products  [PDF] Draft
note*
2/18/1997
Lyme Disease — Developing Antimicrobial Drugs for Treatment [PDF] Draft
note*
7/22/1998
Nosocomial Pneumonia — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development  [PDF] or [HTML]
Final
10/30/2007
Secondary Bacterial Infections of Acute Bronchitis — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention [PDF] or [HTML] Draft
note*
11/21/2007
Streptococcal Pharyngitis and Tonsillitis — Developing Antimicrobial Drugs for Treatment [PDF] Draft
note*
7/22/1998
Uncomplicated and Complicated Skin and Skin Structure Infections — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998
Uncomplicated Gonorrhea — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998,
Uncomplicated Urinary Tract Infections — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998

Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination  [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
3/8/2004
Vulvovaginal Candidiasis — Developing Antimicrobial Drugs for Treatment  [PDF] Draft
note*
7/22/1998

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Clinical/Medical

Title and Format Type Issue Date
Acceptance of Foreign Clinical Studies [HTML] or [PDF] Final 3/12/2001

Acne Vulgaris: Developing Drugs for Treatment [HTML] or [PDF]
Federal Register Notice [TXT] [ PDF]

Draft
note*
9/16/2005
Allergic Rhinitis: Clinical Development Programs for Drug Products [HTML] or [PDF] Draft
note*
6/2000
Antianxiety Drugs--Clinical Evaluation  [PDF] Final 9/1977
Antidepressant Drugs--Clinical Evaluation   [PDF] Final 9/1977
Available Therapy [HTML] or [PDF] Final 7/22/2004
Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application [HTML] or [PDF] Final 8/13/2004
Cancer Drug and Biological Products - Clinical Data in Marketing Applications [HTML] or [PDF] Final 10/11/2001
Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment [PDF] or [HTML] Final 6/1/2006
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment [PDF] or [HTML] Draft
note*
11/8/2007

Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis [PDF]
Federal Register Notice: [ TXT ] [ PDF ]

Draft
note*
7/07/1999
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)  [HTML] or [PDF] Final 1/1999
Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice) 

Final
 

Withdrawn
8/5/2003
Clinical Evaluation of  Antacid Drugs  (Withdrawn per July 20, 2004, Federal Register notice.) Final Withdrawn
7/20/2004
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)  [PDF] Final 9/1977
Rev.4/1988
Clinical Evaluation of Antidiarrheal Drugs  (Withdrawn per July 20, 2004, Federal Register notice.)

Final
Withdrawn

Withdrawn
7/20/2004
Clinical Evaluation of Antiepileptic Drugs (adults and children)  [PDF]

Final

1/1981
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs  (Withdrawn per July 20, 2004, Federal Register notice.) 

Final
Withdrawn

Withdrawn
7/20/2004
Clinical Evaluation of General Anesthetics  [PDF]

Final

5/1982
Clinical Evaluation of Laxative Drugs  (Withdrawn per July 20, 2004, Federal Register notice.)

Final
Withdrawn

Withdrawn
7/20/2004
Clinical Evaluation of Lipid-Altering Agents [PDF] Draft
note*
 10/1990
Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.)

Final
Withdrawn

Withdrawn
7/20/2004

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics [HTML] or [PDF]

Final 5/15/2007
Collection of Race and Ethnicity Data in Clinical Trials [HTML] or [PDF] Final 9/16/2005
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products  [PDF] Final 11/1995
Developing Medical Imaging Drug and Biological Products
  • Part 1: Conducting Safety Assessments [HTML] or [PDF]
  • Part 2: Clinical Indications [HTML] or [PDF]
  • Part 3: Design, Analysis, and Interpretation of Clinical Studies [HTML] or [PDF]
Final

6/17/2004
Developing Products for Weight Management Revision 1 [PDF] or [HTML] Draft
note*
2/14/2007
Development and Use of Risk Minimization Action Plans [HTML] or [PDF] Final 3/24/2005

Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
5/2000

Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*
9/6/2002
Establishing Pregnancy Exposure Registries [HTML] or [PDF] Final 8/2002
Establishment and Operation of Clinical Trial Data Monitoring Committees [PDF] Final 3/27/2006

Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation or [PDF]
Federal Register Notice [TXT] [PDF]

Draft
note*

1/2003
Evaluating the Risks of Drug Exposure in Human Pregnancies [HTML] or [PDF] Final 4/27/2005
Exercise-Induced Bronchospasm (EIB) — Development of Drugs to Prevent EIB [PDF]
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*
 2/2002
Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications [HTML] or [PDF] Final 4/13/2006
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]
Draft
note*
5/2000
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products [HTML] or [PDF] Final 12/1998
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer  [PDF] Final Posted 3/2/1998
FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal Register notice.) Final
Withdrawn
Withdrawn
7/20/2004

Format and Content of the Clinical and Statistical Sections of an Application  [PDF] Final 7/1988
Formatting, Assembling and Submitting New Drug and Antibiotic Applications*  [PDF] Final 2/1987
General Considerations for the Clinical Evaluation of Drugs  [PDF] Final  
General Considerations for the Clinical Evaluation of Drugs in Infants and Children  [PDF] Final  9/77
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]
Draft
note*
 6/24/ 2005
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment [HTML] or [PDF] Final 3/24/2005
Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees [PDF] Final 3/27/2006
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research
Federal Register Notice
Draft
note*
8/29/2006
Guidance for the Development of Vaginal Contraceptive Drugs (NDA)[PDF] Final 3/2/1998
Hypnotic Drugs--Clinical Evaluation [PDF]

Final

9/77
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer [HTML] or [PDF] Final Revised 1/15/2004
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems [PDF]
Federal Register Notice [TXT] [PDF]
Draft
note*
7/2002
Integration of Dose-Counting Mechanisms into MDI Drug Products [HTML] or [PDF] Final  3/2003
Internal Radioactive Contamination —Development of Decorporation Agents [HTML] or [PDF] Final 3/1/2006
Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing [HTML] or [PDF] Final 2/2001
Local Anesthetics--Clinical Evaluation   [PDF] Final 3/2/1998
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis [PDF] Draft
note*
6/6/2007
MDI and DPI Drug Products--Clinical Development Programs for  [PDF] Final 9/19/1994
Pediatric Use Supplements--Content and Format [PDF] Final 5/1996
Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer [PDF] Final Posted 3/2/1998
Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children [PDF] or [HTML] Final 3/5/2007
OTC Treatment of Herpes Labialis with Antiviral Agents [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]
Draft
note*
3/8/2000
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]
Draft
note*
2/2/2006
Pediatric Oncology Studies In Response to a Written Request [HTML] or [PDF]
Federal Register Notice [TXT] [PDF]
Draft
note*
6/2000
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report [PDF]   Final 8/27/1997

Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application [PDF] or [HTML]

Draft
note*

10/11/2007

Postmarketing Reporting of Adverse Drug Experiences  [PDF] Final  3/1992
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis  [PDF] Draft
note*
4/1994
Premarketing Risk Assessment [HTML] or [PDF] Final 3/24/2005
Preparation of Investigational New Drug Products (Human and Animal) [PDF] Final 11/1992
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products  [PDF] Final

5/14/1998
Prussian Blue Drug Products — Submitting a New Drug Application [HTML] or [PDF] Final 1/2003
Psychoactive Drugs in Infants and Children--Clinical Evaluation   [PDF] Final 3/2/1998
Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act [PDF] Draft
note*
12/21/2007
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) [HTML] or [PDF] Draft
note*
Posted 12/1/2000
Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment [PDF] or [HTML] Draft
note*
Posted 11/21/2006
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs  [PDF] Final 7/22/1993
Study of Drugs Likely to be used in the Elderly  [PDF] Final 11/1989
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications [HTML] or [PDF] Final 8/1999
Summary for New Drug and Antibiotic Applications--Format and Content of the *  [PDF] Final 2/1987
Systemic Lupus Erythematosus --Developing Drugs for Treatment [HTML] or [PDF] Draft
note*
3/28/2005
The Use of Clinical Holds Following Clinical Investigator Misconduct [HTML] or [PDF] Final 9/2004
Waiver of IRB Requirements for Drug and Biological Product Studies [PDF] Final 1/2006

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Clinical Pharmacology

Title and Format Type Issue Date
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
Issued 2/7/05
Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling [PDF] or [HTML]
Federal Register Notice: [TXT] [PDF]
Draft
note*
Issued 9/11/2006
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro [PDF] (Issued, Posted 4/8/1997) Final 4/1997
Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications [HTML] or [PDF] Final 5/5/2003
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application*  [PDF] Final 2/1987
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products  [PDF] Draft
note*

11/1998
In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling [HTML] or [PDF] Final 11/24/1999
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling [HTML] or [PDF] Final

Posted 5/30/2003
Pharmacokinetics in Patients with Impaired Renal Function [PDF] Final 5/14/1998
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
10/29/2004
Population Pharmacokinetics [PDF] (Issued , Posted 2/10/1999) Final 2/1999

Combination Products (Drug/Device/Biologic)

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Drug Safety

Title and Format
Type
Issue Date
Adverse Event Reporting-- Improving Human Subject Protection [PDF]
Draft
note*
4/9/2007
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review [HTML] or [PDF]

Final

2/2005
Drug-Induced Liver Injury:  Premarketing Clinical Evaluation [PDF] or [HTML]
Draft
note*
10/24/2007
Drug Safety Information - FDA's Communication to the Public [PDF] or [HTML]
Federal Register Notice [TXT] [PDF]
Final
3/2/2007

Electronic Submissions

Title and Format Type Issue Date
Indexing Structured Product Labeling [PDF] or [ HTML] Draft
note*
3/13/2007
Part 11, Electronic Records; Electronic Signatures — Scope and Application [HTML] [PDF]

Final

9/3/2003
Providing Regulatory Submissions in Electronic Format — ANDAs
Withdrawn FR Notice 10/5/2006
Final
Withdrawn
FR Notice

6/2002
Providing Regulatory Submissions in Electronic Format - Annual Reports for NDAs and ANDAs
Withdrawn FR Notice 10/5/2006

Draft
note*
Withdrawn
FR Notice

Posted 8/27/2003
Providing Regulatory Submissions in Electronic Format — Content of Labeling [HTML] or [PDF] Final 4/20/2005
Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications  [HTML] or [PDF].  To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http://www.fda.gov/cber/esub/esub.htm.
For CDER, this Web site is http://www.fda.gov/cder/regulatory/ersr/ectd.htm.  
Final 04/19/2006
Providing Regulatory Submissions in Electronic Format - General Considerations or [PDF]  (Issued , Posted 10/22/2003)
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
10/2003
Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports [HTML] or [PDF] Federal Register Notice [ TXT ] [ PDF ] Draft
note*

5/2001
Providing Regulatory Submissions in Electronic Format - Postmarketing Periodic Adverse Drug Experience Reports [HTML] or [PDF]
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*

Posted 6/23/2003
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling [HTML] or [PDF]
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*

1/2001
Providing Regulatory Submissions in Electronic Format--Receipt Date [HTML] or [PDF] Draft
note*
6/4/2007
Regulatory Submissions in Electronic Format; General Considerations  [PDF] Final 1/1999
Regulatory Submissions in Electronic Format; New Drug Applications 
Withdrawn FR Notice 10/5/2006
Final
Withdrawn
FR Notice
1/1999
SPL Standard for Content of Labeling Technical Qs & As [HTML] or [PDF] Final 12/2005

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Generics

Title and Format Type Issue Date

180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day [HTML] or [PDF]

Final 7/2003
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs [HTML] or [PDF] Final  12/2000
ANDAs: Impurities in Drug Products [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
8/26/2005
ANDA's: Impurities in Drug Substances [HTML] or [PDF] Final 11/1999
ANDAs: Impurities in Drug Substances [HTML] or [PDF]
Federal Register Notice
 [ TXT ] [ PDF ]
Draft
note*
1/28/2005
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information [PDF] Final 7/6/2007
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF Final  3/2000
Handling and Retention of Bioavailability and Bioequivalence Testing Samples [HTML] or [PDF] Final 5/25/2004
Individual Product Bioequivalence Recommendations [PDF]
List of Product Bioequivalence Recommendations
Draft
note*
5/30/2007
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past.  [PDF] Final 8/1995
Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process [PDF] Final 10/1994
Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy  [PDF] Final 4/1994
Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters  [PDF] Final 7/1992
Letter on the provision of new procedures and policies affecting the generic drug review process  [PDF] Final 3/1989
Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions [PDF] Final 11/1990
Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act  [PDF] Final 3/1985
Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law [PDF] Final 1/1993
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements  [PDF] Final 8/1993
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 -- Questions and Answers [HTML] or [PDF].
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
10/2004
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications [HTML] or [PDF] Final 12/2001
Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing [HTML] or [PDF] Final 10/25/2005
Revising ANDA Labeling Following Revision of the RLD Labeling [HTML] or [PDF] Final 4/26/2000
Variations in Drug Products that May Be Included in a Single ANDA [PDF] Final 12/1998

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Good Review Practices

Title and Format Type Issue Date
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review [HTML] or [PDF] Final 2/2005
Pharmacology/Toxicology Review Format [PDF]  

Final

5/2001

International Conference on Harmonisation -  Efficacy

Title and Format Type Issue Date
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions  [PDF] Final 3/1995
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting  [PDF] Final 3/1995

E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports   [PDF]
  • E2BM Data Elements for Transmission Of Individual Case Safety Reports  (Issued 4/2002, Posted 4/4/2002) [PDF]
    • E2B(M) Questions and Answers [HTML] or [PDF] (Revised 3/09/2005,  Posted, 3/16/2005)
Final 1/15/1998
E2B(R) Clinical Safety Data Management:  Data Elements for Transmission of Individual Case Safety Reports [HTML] or [PDF] (Issued , Posted 9/30/2005)
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
9/30/2005
E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs  [PDF] Final 5/19/1997
E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs [HTML] or [PDF] Final 2/5/2004
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting [PDF]
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*
9/12/2003
E2E Pharmacovigilance Planning [HTML] or [PDF] Final 3/31/05
E3 Structure and Content of Clinical Study Reports  [PDF] Final 7/1996
E4 Dose-Response Information to Support Drug Registration  [PDF] Final 7/1996
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data [PDF]
  • E5 Questions and Answers [HTML] or [PDF] [Issued 9/27/2006; Posted 9/28/2006]
Final  6/2004
E6 Good Clinical Practice: Consolidated Guideline [PDF]
Spanish Version [PDF]
Final 5/9/1997
E7 Studies in Support of Special Populations: Geriatrics  [PDF] Final 8/1994
E8 General Considerations for Clinical Trials [PDF] Final 12/1997
E9 Statistical Principles for Clinical Trials [PDF] Final 9/1/1998
E10 Choice of Control Group and Related Issues in Clinical Trials [HTML] or [PDF] Final 5/2001
E11 Clinical Investigation of Medicinal Products in the Pediatric Population [PDF] Final 12/2000
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs.  Optional Format: [PDF].
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*
8/2000
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [HTML] or [PDF] Final 10/19/2005
E15 Terminology in Pharmacogenomics [PDF] or [HTML]

Draft
note*

1/8/2007

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International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)

Title and Format Type Issue Date
M2 eCTD: Electronic Common Technical Document Specification [PDF] Final 4/1/2003


3/14/05


8/1/2006

M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals  [PDF] Final 11/1997
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use
  • M4: Organization of the CTD [HTML] or [PDF
    • M4 Granularity Annex  [HTML] or [PDF] (Issued 10/18/2005, Posted 10/18/2005)
    • M4:  The CTD -- General Questions and Answers [HTML] or [PDF] (Issued 12/04, Posted 12/22/2004)
  • M4: The CTD -- Quality [HTML] or [PDF
    • M4: The CTD -- Quality Questions and Answers /Location Issues  [HTML] or [PDF] (Issued 6/2004, Posted 6/8/2004)
  • M4: The CTD -- Efficacy [HTML] or [PDF]
    • M4: The CTD -- Efficacy Questions and Answers [HTML] or [PDF] (Issued 12/2004,  Posted 12/22/2004)
      Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format [esrs/eCTD page].
  • M4: The CTD -- Safety [HTML] or [PDF]
  • M4: The CTD -- Safety Appendices [HTML] or [PDF]
    • M4: The CTD -- Safety Questions and Answers [HTML] or [PDF] (Issued 2/2003, Posted 2/4/2003)
Final

Originally Issued

10/15/2001

M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries [HTML] or  [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
9/2005
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations  [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
9/2001

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International Conference on Harmonisation-Quality

Title and Format Type Issue Date
Q1A(R2) Stability Testing of New Drug Substances and Products [HTML] or [PDF] Final 11/2003
Q1B Photostability Testing of New Drug Substances and Products [HTML] or [PDF] Final 11/1996,
Q1C Stability Testing for New Dosage Forms  [PDF] Final 5/9/1997
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products [HTML] or [PDF] Final 1/2003
Q1E Evaluation of Stability Data [HTML] or [PDF] Final 6/2004
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1 Final Withdrawn 7/6/2006
Q2A Text on Validation of Analytical Procedures  [PDF] Final 3/1995
Q2B Validation of Analytical Procedures: Methodology  [PDF] Final 5/19/1997
Q3A(R) Impurities in New Drug Substances [HTML] or [PDF] Final 2/10/2003
Q3B(R) Impurities in New Drug Products (Revision 2) (HTML) or [PDF] Final 8/4/2006
Q3C Impurities: Residual Solvents or [PDF] 

Q3C Tables and List [HTML] or [PDF]
Appendix 4 [PDF], Appendix 5 [PDF], and Appendix 6 [PDF] (Appendices were issued with the Q3C draft guidance documents)
Maintenance Procedures for Updating

Final 12/24/1997


11/12/2003



2/11/2002

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF]

  • Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF][FINAL]

 

  • Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter [PDF] [Draft-note* posted 12/14/2007]
  • Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter [PDF] [Draft-note* posted 12/14/2007]

Final

 

 

Draft
note*

 

2/20/2007

 

 

12/14/2007

12/14/2007

Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin [PDF] Final

Posted 9/1998
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products [PDF]   Final

2/1996
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products  [PDF] Final 7/1996
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability [PDF] (Issued , Posted 9/21/1998) Final 9/21/1998
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process [HTML] or  [PDF] Final 6/2005
Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. [HTML] or [PDF]  Final 12/29/2000
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products [PDF] Final 8/1999
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients [HTML] or [PDF] Final 8/2001
Q8 Pharmaceutical Development [HTML] or [PDF] Final 5/19/2006
Q8(R1) Pharmaceutical Development Revision 1 [PDF] Draft
note*
1/10/2008
Q9 Quality Risk Management  [PDF] or [HTML] Final 6/1/2006
Q10 Pharmaceutical Quality System[PDF] or [HTML] Draft
note*
7/12/2007

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International Conference on Harmonisation - Safety

Title and Format Type Issue Date
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals  [PDF] Final 3/1996
S1B Testing for Carcinogenicity of Pharmaceuticals  [PDF] Final 2/28/1998
S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals  [PDF] Final 3/1995
S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes [PDF] Final 12/4/1997
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals [PDF] Final 4/1996
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals  [PDF] Final 11/21/1997
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies  [PDF] Final 3/1995
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies  [PDF] Final 3/1995
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) [PDF] or [Text] Final Posted 6/25/99
S5A Detection of Toxicity to Reproduction for Medicinal Products [PDF] Final 9/1994
S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility  [PDF] Final 4/1996
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals [PDF]   Final 11/1997
S7A Safety Pharmacology Studies for Human Pharmaceuticals [HTML] or [PDF] Final 7/2001
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [HTML] or [PDF] Final 10/19/2005
S8 Immunotoxicity Studies for Human Pharmaceuticals [HTML] or [PDF] Final 4/12/2006

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Investigational New Drug Applications

Title and Format Type Issue Date
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs  [PDF]

Final

11/1995

Industry Letters

Title and Format Type Issue Date
Continuation of a series of letters communicating interim and informal generic drug policy and guidance.  Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program  [PDF] Final Posted 3/2/1998
Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required  [PDF] Final Posted 3/2/1998
Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act.  Three year exclusivity provisions of Title I  [PDF] Final Posted 3/2/1998
Implementation of the Drug Price Competition and Patent Term Restoration Act.   Preliminary Guidance  [PDF] Final Posted 3/2/1998
Implementation Plan USP injection nomenclature  [PDF] Final Posted 3/2/1998
Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C  [PDF] Final Posted 3/2/1998
Sixth of a series of informal notice letters about the Act discussing 3-and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act  [PDF] Final Posted 3/2/1998
Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)  [PDF] Final Posted 3/2/1998
Third of a series of letters regarding the implementation of the Act  [PDF] Final Posted 3/2/1998
Year 2000 Letter from Dr. Janet Woodcock [PDF] Final 10/19/1998

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Labeling

Title and Format Type Issue Date

Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format [HTML] or [PDF]

Final 1/18/2006
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format [HTML] or [PDF] Final 1/18/2006
Content and Format for Geriatric Labeling [HTML] or [PDF] Final 10/2001
Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products [HTML] or [PDF] Draft
note*
4/6/2007
Labeling for Combined Oral Contraceptives [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
3/2/2004
Labeling for Human Prescription Drugs -- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information [HTML] or [PDF] Draft
note*
5/15/2007
Labeling for Human Prescription Drug and Biological Products — Implementing the New Content and Format Requirements [HTML] or [PDF]
Federal Register Notice
[ TXT ] [ PDF ]
Draft
note*
1/18/2006
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)  [PDF] Draft
note*
6/1998
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
11/15/2005
Public Availability of Labeling Changes in "Changes Being Effected" Supplements [PDF] or [HTML] Federal Register Notice: [TXT] [PDF] Draft
note*
9/19/2006
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format [HTML] or [PDF] Draft
note*
1/18/2006

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Microbiology

Title and Format Type Issue Date
Format and Content of the Microbiology Section of an Application*  [PDF] Final 1990

Modernization Act of 1997

Title and Format Type Issue Date
Changes to an Approved NDA or ANDA  [HTML] or [PDF] Final 4/2004
Classifying Resubmissions in Response to Action Letters  [PDF] Final 5/14/1998
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act [PDF] Final 11/1998
Fast Track Drug Development Programs - Designation, Development, and Application Review [HTML] or [PDF] (Posted 7/22/2004)
Appendix 2 [PDF] ;  Appendix 3  consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 [PDF]   [Appendices are scanned copies, which will be replaced by final versions]
Final 11/17/1998
Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] Final

 2/2000
Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] Final 2/2000
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees [PDF] Final

10/1998
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements [PDF] Final 7/1998
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [HTML] or [PDF] Final 3/2002
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
1/2004
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs  Final 4/1998

PET Drug Applications - Content and Format for NDAs and ANDAs [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]

  • Sample formats for chemistry, manufacturing, and controls sections [PDF]
  • Sample formats for labeling [PDF]
  • Sample formats for Form FDA 356h [PDF]
  • Sample formats for user fee Form FDA 3397 [PDF]
Draft
note*
3/7/2000
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products [PDF] Final 5/14/1998
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF] Final 9/1999

Posted 7/27/1999

Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act [PDF] Final

Revised
5/1998
Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML] or [PDF] Draft
note*
4/4/2001
Standards for Prompt Review of Efficacy Supplements  [PDF] Final 5/15/1998
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications [PDF]   Final 8/1998
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  [HTML] or [PDF] Final 10/2000

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Over-the-Counter (OTC) Guidances

Title and Format Type Issue Date
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) [PDF]  Final 5/1984
General Guidelines for OTC Combination Products [PDF] Final 11/1978
Labeling OTC Human Drug Products Questions and Answers [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
1/2005
Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
12/2000
Labeling OTC Human Drug Products (Small Entity Compliance Guide) [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
12/2004
Labeling OTC Human Drug Products Updating Labeling in ANDAs [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
  • Additional examples 1 [PDF]  (3/19/2001)
  • Additional examples 2 [PDF]  (3/26/2001)
  • Additional examples 3 [PDF]  (3/26/2001)
Draft
note*
2/21/2001
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs [HTML] or [PDF
Example Drug Facts Labels
  • Acetaminophen 120 mg in a Suppository Dosage Form [PDF]
  • Acetaminophen 325 mg in a Suppository Dosage Form [PDF]
  • Acetaminophen 650 mg in a Suppository Dosage Form [PDF]
  • Cimetidine 200 mg in a Tablet Dosage Form [PDF]
  • Clemastine Fumerate 1.34 mg in a Tablet Dosage Form [PDF]
  • Doxylamine Succinate 25 mg Tablet Dosage Form [PDF]
  • Ibuprofen 200 mg in a Tablet/Capsule Dosage Form [PDF]
  • Loperamide HCl in a Liquid Dosage Form [PDF]
  • Loperamide HCl in a Tablet/Caplet Dosage Form [PDF]
  • Miconazole Nitrate Vaginal Products [PDF]
  • Minoxidil Topical Solution 2% for Men and Women [PDF]
  • Minoxidil Topical Solution 5% for Men [PDF]
  • Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form [PDF]
  • Pseudoephedrine HCl Extended-Release Tablets 120 mg [PDF]
Final 10/2002
Labeling OTC Human Drug Products Using a Column Format [HTML] or [PDF] Final 12/2000
Time and Extent Applications [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
2/2004
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) [PDF Final 10/1978

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Pharmacology/Toxicology

Title and Format Type Issue Date
Carcinogenicity Study Protocol Submissions [HTML] or [PDF] Final 5/22/2002
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products [HTML] or [PDF] Final 10/2000
Developing Medical Imaging Drug and Biological Products
  • Part 1: Conducting Safety Assessments [HTML] or [PDF]
Final 6/17/2004
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers [HTML] or [PDF] Final 7/21/2005
Exploratory IND Studies [HTML] or [PDF] Final 1/12/2006
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*[PDF]  Final 2/1987
Immunotoxicology Evaluation of Investigational New Drugs [HTML] or [PDF] Final 10/2002
Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities [PDF] (Issued , Posted 11/9/2001)
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
11/2001
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
Draft
note*
6/17/2005
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives Final 10/96
Updated
7/2005
Nonclinical Safety Evaluation of Drug or Biologic Combinations [HTML] or [PDF] Final 3/14/2006
Nonclinical Safety Evaluation of Pediatric Drug Products [HTML] or [PDF] Final 2/14/2006
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients [HTML] or [PDF] Final 05/18/2005
Photosafety Testing [HTML] or [PDF] Final 5/7/2003
Recommended Approaches to Integration of Genetic Toxicology Study Results [HTML] or [PDF] Final 1/3/2006
Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies [PDF] Final 3/2/1998
Safety Testing of Drug Metabolites [PDF] or [HTML]
Final

2/14/2008

Single Dose Acute Toxicity Testing for Pharmaceuticals [PDF Final 8/1996
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
5/2001

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Procedural

Title and Format Type Issue Date
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  [PDF] Final 6/1998
Applications Covered by Section 505(b)(2) [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
10/1999
Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administation [PDF]

Draft
note*

 

12/2006
Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA [HTML] or [PDF] Final Posted 10/1/2003
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA [HTML] or [PDF]
  • Paperwork Reduction Act Burden Statement [HTML] or [PDF] (Posted 7/27/2004)
Final Posted 10/1/2003
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF Final Posted 3/27/2000
Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000 [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
12/1999
Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF
Draft
note*
2/14/2002
Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 [HTML] or [PDF] Final 11/1999
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy [PDF] or [HTML] Final 6/3/2003
Emergency Use Authorization of Medical Products; Availability [PDF] Draft
note*
7/5/2005
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act [PDF Final 11/1998
Fast Track Drug Development Programs - Designation, Development, and Application Review  [HTML] or [PDF]
Appendix 2 [PDF] ;  Appendix 3  consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 [PDF]  [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)
Final 1/12/2006
FDA Export Certicates [HTML] or [PDF] Final 7/2004
Financial Disclosure by Clinical Investigators Final 3/27/2001
Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV [PDF] or [HTML] Final 10/17/2006
Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] Final

2/2000
Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] Final  2/2000
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
5/14/2001
Good Review Management Principles and Practices for PDUFA Products [HTML] or [PDF] Final 3/2005
Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [HTML] or [PDF] Draft
note*
7/2/2007
Process for Handling Referrals to FDA Under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations [PDF] Final 12/22/2006
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations [HTML] or [PDF] Final Revised 6/2003
How to Comply with the Pediatric Research Equity Act [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
9/7/2005
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees [PDF] Final 10/1998
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements [PDF]  Final 7/1998
Independent Consultants for Biotechnology Clinical Trial Protocols - [HTML] or [PDF] Final 8/18/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
1/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [HTML] or [PDF] Final 3/2002
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act [HTML] or [PDF] Final 11/2001
Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications [HTML] or [PDF] Final 7/2001
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs [PDF Final 4/1998
PET Drug Applications - Content and Format for NDAs and ANDAs or [PDF] (Issued , Posted 3/7/2000)
Federal Register Notice: [ TXT ] [ PDF ]
  • Sample formats for chemistry, manufacturing, and controls sections [PDF] 
  • Sample formats for labeling [PDF] 
  • Sample formats for Form FDA 356h [PDF] 
  • Sample formats for user fee Form FDA 3397 [PDF] 
Draft
note*
3/7/2000
Pharmacogenomic Data Submissions [HTML] or [PDF]
  • Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 [HTML] or [PDF]
Final 3/2005
Pharmacogenomic Data Submissions — Companion Guidance [PDF] or [HTML] Draft
note*
8/28/2007
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines [PDF] 
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
3/9/2001
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies [HTML] or [PDF]
  • KI in Radiation Emergencies-Questions and Answers [HTML] or [PDF]
Final 12/10/2001

12/23/2002

Potassium Iodide Tablets - Shelf Life Extension [PDF] Final  3/8/2004
Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees [PDF] Draft
note*
3/21/2007
Protecting the Rights, Safety, and Welfare of Study Subjects- Supervisory Responsibilities of Investigators [PDF] Draft
note*
6/7/2007
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF] Final 9/1999
Reduction of Civil Money Penalties for Small Entities Final 3/20/2001
Refusal to File [PDF]  Final 7/12/1993
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act [PDF Final Revised 5/1998,
Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997  [HTML] or [PDF]     Final 2/15/2006
Special Protocol Assessment [HTML] or [PDF] Final 5/2002
Standards for Prompt Review of Efficacy Supplements  [PDF] Final 5/15/1998
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  [HTML] or [PDF] Final 10/2000
Submitting Debarment Certification Statements  [PDF] Draft
note*
10/2/98
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
9/5/2001
Target Product Profile -- A Strategic Development Process Tool [PDF] or [HTML] Draft
note*
3/29/2007
The Use of Clinical Holds Following Clinical Investigator Misconduct   [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
4/2002
Useful Written Consumer Medication Information (CMI) [HTML] or  [PDF] Final 7/17/2006
Using a Centralized IRB Review Process in Multicenter Clinical Trials [HTML] or [PDF] Final 3/15/2006
Waiver of IRB Requirements for Drug and Biological Product Studies [PDF] Final 1/2006
Women and Minorities Guidance Requirements  [PDF] Final 7/20/1998

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Small Entity

Title and Format Type Issue Date
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide [PDF Final 11/7/2001
Labeling OTC Human Drug Products (Small Entity Compliance Guide) [PDF]
Federal Register Notice: [ TXT ] [ PDF ]
Draft
note*
12/2004

User Fees

Title and Format Type Issue Date
Attachment G -- Draft Interim Guidance Document for Waivers of and Reductions in User Fees [PDF]  Draft
note*
7/16/1993
Classifying Resubmissions in Response to Action Letters [PDF]  Final 5/14/1998
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act [HTML] or [PDF] Final 6/1999

Guidance for Industry and FDA Staff: Application User Fees for Combination Products  [PDF]

Final 4/2005
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act [HTML] or [PDF] Final 11/2001
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees [HTML] or [PDF] Final 12/30/2004
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR [PDF] or [HTML] (Issued , Posted 2/7/2007)
Final 2/7/2007

Also see Current Good Manufacturing Practice Regulations

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
(Posted 8/11/1997)

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Date updated: February 20, 2008

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