[U.S. Food and Drug Administration]

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.

Most of these documents are in Adobe Acrobat format Adobe Acrobat Symbol, also known as PDF.  The free upgrade to Adobe Acrobat 4.0 or higher is recommended, especially if you have difficulty opening any of the documents below.  Another method of obtaining guidance documents is through the Division of Drug Information.

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Advertising 

  1. Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling Adobe Acrobat Symbol (Issued 12/1997, Posted 1/12/1998)
  2. Consumer-Directed Broadcast Advertisements [HTML] or [PDF] (Issued 8/1999, Posted 8/6/1999)
    Questions and Answers (Posted 8/6/1999)
  3. Industry-Supported Scientific and Educational Activities [HTML] or [PDF]  (Issued 12/3/1997, Posted 12/4/1997)

Advertising Draft

  1. Accelerated Approval Products: Submission of Promotional Materials Adobe Acrobat Symbol (Posted 3/26/1999)
  2. Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling Adobe Acrobat Symbol (Issued 1/1999, Posted 3/12/1999)
  3. Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs) Adobe Acrobat Symbol (Issued 12/1997. Posted 1/5/1998)
  4. Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements [HTML] or [PDF] (Issued 4/2001, Posted 4/20/2001]

Biopharmaceutics

  1. Bioanalytical Method Validation [HTML] or [PDF] (Issued 5/2001, Posted 5/22/2001)
  2. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations [Word] or [PDF] (Issued 3/2003, Posted 3/19/2003)
  3. Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance) PDF document
  4. Clozapine Tablets in Vivo Bioequivalence and in Vitro Dissolution Testing PDF document (Issued 11/15/1996, Reposted 10/15/1998)
  5. Corticosteroids, Dermatologic (topical) In Vivo PDF document (Issued 6/2/1995, Posted 3/6/1998)
  6. Dissolution Testing of Immediate Release Solid Oral Dosage Forms PDF document or WordPerfect 6.x Version (Issued 8/1997, Posted 8/25/1997)
  7. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations PDF document (Issued 9/1997, Posted 9/26/1997)
  8. Food-Effect Bioavailability and Fed Bioequivalence Studies [Word] or [PDF] (Issued 12/2002, Posted 1/30/2003) 
  9. Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro  PDF document (Issued 6/27/1989, Posted 3/2/1998)
  10. Phenytoin/Phenytion Sodium (capsules, tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing  PDF document (Issued 3/4/1994, Posted 3/2/1998)
  11. Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing  PDF document (Revised 6/6/1994, Posted 6/22/1998)
  12. Statistical Approaches to Establishing Bioequivalence [HTML] or [PDF] (Issued 2/2001, Posted 2/1/2001)
  13. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.  Optional Format: PDF. (Issued 8/2000, Posted 8/31/2000)

Biopharmaceutics (Draft)

  1. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action [Word] or [PDF] (Posted 4/2/2003)
  2. Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence [HTML] or [PDF] (Issued 3/6/2000, Posted 3/6/2000)
  3. In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies PDF document (Issued 12/10/1997, Posted 12/10/1997)  Bioequivalence Studies Data and Detailed Statistical Methodology (Posted 3/2/1998)
  4. Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing PDF document (Issued 8/2002, Posted 8/6/2002)

Chemistry

  1. BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation [HTML] or [PDF]  (Issued 2/2001, Posted 2/16/2001) 
  2. Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products PDF document (Issued 7/1997, Posted 7/28/1997)
  3. Changes to an Approved NDA or ANDA [HTML] or [PDF] (Issued 11/1999, Posted 11/19/1999)
  4. Changes to an Approved NDA or ANDA: Questions and Answers [HTML] or [PDF] (Issued 1/2001, Posted 1/22/2001)
  5. Container Closure Systems for Packaging Human Drugs and Biologics [HTML] or [PDF] (Issued 5/1999, Posted 7/6/1999)
  6. Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
  7. Development of New Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996)
  8. Drug Master Files (9/1/1989)
          Current DMF Information (e.g. lists, addresses, etc.) 
  9. Drug Master Files for Bulk Antibiotic Drug Substances [PDF] or [Word] (Issued 11/1999, Posted 11/26/1999)
  10. Environmental Assessment of Human Drug and Biologics Applications PDF document (Issued 7/1998, Posted 7/24/98)
  11. Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* PDF document (Issued 2/1987, Posted 3/2/1998)
  12. Format and Content for the CMC Section of an Annual Report (9/1/1994) PDF document
  13. INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information [Word] or [PDF] (Posted 5/20/2003)
  14. IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information [HTML] or [PDF] (Issued 5/2001, Posted 6/4/2001)
  15. Monoclonal Antibodies Used as Reagents in Drug Manufacturing [HTML] or [PDF] (Issued 3/2001, Posted 3/28/2001)
  16. Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML] or [PDF] (Issued 7/2002, Posted 7/3/2002)
  17. NDAs: Impurities in Drug Substances [HTML] or [PDF] (Issued 2/2000, Posted 2/24/2000)
  18. PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites PDF document (Issued 4/28/1998, Posted 4/28/1998)

  19. The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) (12/20/2000)

  20. 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 document
  21. SUPAC-IR Questions and Answers about SUPAC-IR Guidance (2/18/1997)
  22. SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum PDF document (Issued 1/1999, Posted 2/25/1999)
  23. 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 document (Issued 10/6/1997, Posted 10/6/1997)
  24. 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 document (Issued 5/1997; Posted 6/16/1997)
  25. Reviewer Guidance, Validation of Chromatographic Methods PDF document
  26. Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products PDF document
  27. Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances PDF document
  28. Submitting Documentation for the Manufacturing of and Controls for Drug Products* [HTML] or [PDF] (Issued 2/1987, Posted 3/2/1998)
  29. Submitting Documentation for the Stability of Human Drugs and Biologics* PDF document (Issued 2/1987, Posted 3/2/1998)
  30. Submitting Samples and Analytical Data for Methods Validation
  31. Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances PDF Doc

Chemistry (Draft)

  1. Analytical Procedures and Methods Validation. Optional format: PDF. (Issued 8/2000, Posted 8/30/2000)
  2. Botanical Drug Products. Optional format: PDF. (Issued 8/2000, Posted 8/10/2000)
  3. Comparability Protocols -- Chemistry, Manufacturing, and Controls Information [Word] or [Acrobat] (Issued 2/2003, Posted 2/20/2003)
  4. Drug Product: Chemistry, Manufacturing, and Controls Information  PDF Doc (Issued 1/2003, Posted 1/28/2003)
  5. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products [HTML] or [PDF] or (Issued 11/13/1998, Posted 11/19/1998, HTML Posted 9/27/1999)
  6. Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. PDF Doc  (Issued 7/2002, Posted 8/20/2002)
  7. Stability Testing of Drug Substances and Drug Products PDF Doc (Issued 6/5/1998, Posted 6/8/1998)
  8. SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum PDF Doc (Issued 12/1998, Posted 1/5/1999)

Clinical/Antimicrobial

  1. Antiretroviral Drugs Using Plasma HIV RNA Measurements — Clinical Considerations for Accelerated and Traditional Approval [Word] or [PDF] (Issued 10/2002, Posted 10/31/2002)
  2. Clinical Development and Labeling of Anti-Infective Drug Products [HTML] or [PDF]  (Issued 10/1992, Posted 3/2/1998, Revised 2/12/2001)
  3. Clinical Evaluation of Anti-Infective Drugs (Systemic) PDF document (Issued 9/77, Posted 3/2/1998)
  4. Preclinical Development of Antiviral Drugs PDF document

Clinical/Antimicrobial (Draft)

  1. Acute Bacterial Exacerbation of Chronic Bronchitis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  2. Acute Bacterial Meningitis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  3. Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  4. Acute or Chronic Bacterial Prostatitis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  5. Acute Otitis Media — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  6. Bacterial Vaginosis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  7. Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs for Treatment [HTML] or [PDF] (Issued 10/1999, Posted 10/18/1999)
  8. Community-Acquired Pneumonia — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  9. Complicated Urinary Tract Infections and Pyelonephritis — Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) [HTML] or [PDF]
  10. Developing Antimicrobial Drugs — General Considerations for Clinical Trials PDF Doc (Issued 7/22/1998, Posted 7/22/1998) [Main Document]
  11. Empiric Therapy of Febrile Neutropenia — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  12. Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (2/18/1997) PDF document
  13. Inhalational Anthrax (Post Exposure) -- Developing Antimicrobial Drugs (Issued 3/15/2002, Posted 3/15/2002) [HTML] or [PDF]
  14. Lyme Disease — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  15. Nosocomial Pneumonia — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  16. Secondary Bacterial Infections of Acute Bronchitis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  17. Streptococcal Pharyngitis and Tonsillitis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  18. Uncomplicated and Complicated Skin and Skin Structure Infections — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  19. Uncomplicated Gonorrhea — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  20. Uncomplicated Urinary Tract Infections — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)
  21. Vulvovaginal Candidiasis — Developing Antimicrobial Drugs for Treatment PDF Doc (Issued 7/22/1998, Posted 7/22/1998)

Clinical/Medical

  1. Acceptance of Foreign Clinical Studies [HTML] or [PDF] (Posted 3/12/2001)
  2. Cancer Drug and Biological Products - Clinical Data in Marketing Applications [HTML] or [PDF] (Posted 10/11/2001)
  3. Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (Issued 1/1999, Posted 2/16/1999) [HTML] or [PDF]
  4. Clinical Development Programs for MDI and DPI Drug Products PDF document (Issued 9/19/1994, Posted 3/2/1998)
  5. Clinical Evaluation of Analgesic Drugs PDF document (Issued 12/1992, Posted 3/2/1998)
  6. Clinical Evaluation of  Antacid Drugs PDF document (Issued, 4/1/78, Posted 3/2/1998)
  7. Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children) PDF document
  8. Clinical Evaluation of Antianxiety Drugs PDF document (Issued 9/77, Posted 3/2/1998)
  9. Clinical Evaluation of Antidepressant Drugs PDF document (Issued 9/77, Posted 3/2/1998)
  10. Clinical Evaluation of Antidiarrheal Drugs PDF document (Issued 9/77, Posted 3/2/1998)
  11. Clinical Evaluation of Antiepileptic Drugs (adults and children) PDF document (Issued 1/1981, Posted 3/2/1998)
  12. Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs PDF document (Issued 9/77, Posted 3/2/1998)
  13. Clinical Evaluation of General Anesthetics PDF document (Issued 5/1982, Posted 3/2/1998)
  14. Clinical Evaluation of Hypnotic Drugs PDF document (Issued 9/77, Posted 3/2/1998)
  15. Clinical Evaluation of Laxative Drugs PDF document (Issued 4/78, Posted 3/2/1998)
  16. Clinical Evaluation of Local Anesthetics PDF document (Posted 3/2/1998)
  17. Clinical Evaluation of Psychoactive Drugs in Infants and Children PDF document (Posted 3/2/1998)
  18. Clinical Evaluation of Radiopharmaceutical Drugs PDF document (Posted 3/2/1998)
  19. Content and Format for Pediatric Use Supplements PDF document
  20. Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products PDF document
  21. Establishing Pregnancy Exposure Registries [Word] or [PDF] (Issued 8/2002, Posted 9/20/2002)
  22. FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products [HTML] or [PDF] (Issued 12/1998, Posted 2/2/1999, HTML posted 9/14/1999)
  23. FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer PDF document (Posted 3/2/1998)
  24. FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer PDF document (Posted 3/2/1998)
  25. Format and Content of the Clinical and Statistical Sections of an Application PDF document (Issued 7/1988, Posted 5/21/1997)
  26. Format and Content of the Summary for New Drug and Antibiotic Applications* PDF document (Issued 2/1987, Posted 3/2/1998)
  27. Formatting, Assembling and Submitting New Drug and Antibiotic Applications* PDF document (Issued 2/1987, Posted 3/2/1998)
  28. General Considerations for the Clinical Evaluation of Drugs PDF document
  29. General Considerations for the Clinical Evaluation of Drugs in Infants and Children PDF document (Issued 9/77, Posted 3/2/1998)
  30. Guidance for the Development of Vaginal Contraceptive Drugs (NDA) PDF document (Posted 3/2/1998)
  31. Integration of Dose-Counting Mechanisms into MDI Drug Products [Word] or [PDF] (Issued 3/2003, Posted 3/12/2003)
  32. Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing [HTML] or [PDF] (Issued 2/2001, Posted 3/8/2001)
  33. Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer PDF document (Posted 3/2/1998)
  34. Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer PDF document (Posted 3/2/1998)
  35. Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report PDF document or WordPerfect 6.x version (Issued 8/27/1997, Posted 8/27/1997)
  36. Postmarketing Reporting of Adverse Drug Experiences PDF document (Issued 3/1992, Posted 3/2/1998)
  37. Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders PDF document (Reposted 1/21/1999)
  38. Preparation of Investigational New Drug Products (Human and Animal) PDF document (Issued 11/1992, Posted 3/2/1998)
  39. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products PDF document (Issued 5/14/1998, Posted 5/14/1998)
  40. Prussian Blue Drug Products — Submitting a New Drug Application [Word] [PDF] (Issued 1/2003, Posted 2/4/2003)
  41. Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs PDF document (Issued 7/22/1993, Posted 3/2/1998)
  42. Study of Drugs Likely to be used in the Elderly PDF document (Issued 11/1989, Posted 3/2/1998)
  43. Submission of Abbreviated Reports and Synopses in Support of Marketing Applications [HTML] or [PDF] (Issued 8/1999, Posted 9/13/1999)

Clinical/Medical (Draft)

  1. Allergic Rhinitis: Clinical Development Programs for Drug Products [HTML] or [PDF] (Issued 6/2000, Posted 6/20/2000)
  2. Available Therapy [HTML] or [PDF] (Posted 2/6/2002)
  3. Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment [HTML] or [PDF] (Issued 6/2000, Posted 6/27/2000)
  4. Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis [Word] or [PDF] (Issued 7/07/1999, Posted 7/14/1999)
  5. Clinical Evaluation of Lipid-Altering Agents (Issued 10/1990, Posted 2/18/1998) PDF document
  6. Clinical Evaluation of Weight-Control Drugs (9/24/1996, Posted 2/18/1998) PDF document
  7. Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Dada Monitoring Committees [HTML] or [PDF] (11/15/2001) 
  8. Developing Medical Imaging Drug and Biological Products
  9. Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis [HTML] or [PDF] (Issued 5/2000, Posted 6/13/2000)
  10. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals [HTML]or [PDF] (Issued 9/6/2002)
  11. Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation [Word] or [PDF] (Issued 1/2003, Posted 1/30/2003)
  12. Evaluation of Human Pregnancy Outcome Data [HTML] or [PDF]  (Issued 6/2/1999, Posted 6/8/99)
  13. Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children [HTML] or [PDF] (Posted 11/6/2001) 
  14. Exercise-Induced Bronchospasm (EIB) — Development of Drugs to Prevent EIB [PDF] (Issued 2/2002, Posted 2/19/2002)
  15. Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment [HTML] or [PDF] (Issued 5/2000, Posted 5/18/2000)
  16. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (3/31/2000)
  17. IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products [PDF] (Issued 4/2002, Posted 4/9/2002)
  18. Inhalation Drug Products Packaged in Semipermeable Container Closure Systems [PDF] (Issued 7/2002, Posted 7/25/2002)
  19. OTC Treatment of Herpes Labialis with Antiviral Agents [HTML] or [PDF] (Issued 3/8/2000, Posted 3/8/2000)
  20. Pediatric Oncology Studies In Response to a Written Request [HTML] or [PDF] (Issued 6/2000, Posted 6/19/2000)
  21. Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis (Issued 4/1994, Posted 2/18/1998) PDF document
  22. Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) [HTML] or [PDF] (Posted 12/1/2000)

Clinical Pharmacology

  1. Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro PDF document (Issued 4/1997, Posted 4/8/1997)
  2. Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications [Word] or [PDF] (Posted 5/5/2003)
  3. Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application* PDF document (Issued 2/1987, Posted 3/2/1998)
  4. In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling [HTML] or [PDF] (Issued 11/24/1999, Posted 11/24/1999)
  5. Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling [Word] or [PDF] (Posted 5/30/2003)
  6. Pharmacokinetics in Patients with Impaired Renal Function PDF document (Issued 5/14/1998, Posted 5/14/1998)
  7. Population Pharmacokinetics PDF document (Issued 2/1999, Posted 2/10/1999)

Clinical Pharmacology (Draft)

  1. General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products PDF document (Issued 11/1998, Posted 11/12/1998)

Compliance

  1. A Review of FDA's Implementation of the Drug Export Amendments of 1986 PDF document (Issued 11/1989, Posted 3/2/1998)
  2. Compressed Medical Gases (Issued 2/1989, Posted 3/10/1997)
  3. Computerized Systems Used in Clinical Trials [HTML] -  [Acrobat Version] (Issued 4/1999, Posted 5/11/1999)
  4. General Principles of Process Validation
  5. Good Laboratory Practice Regulations Questions and Answers PDF document (Posted 3/2/1998)
  6. Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory  [HTML] or [PDF] (Issued and Posted 4/5/2001)
  7. 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 document (Posted 3/2/1998)
  8. Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron PDF document (Issued 6/27/1997, Posted 6/27/1997)
  9. Monitoring of Clinical Investigations PDF document (Posted 3/2/1998)
  10. Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment PDF document (Posted 3/2/1998)
  11. Possible Dioxin/PCB Contamination of Drug and Biological Products [HTML] or [PDF] (Issued 8/23/1999, Posted 8/23/1999)
  12. Street Drug Alternatives [HTML] or [PDF] (Issued 3/2000, Posted 3/31/2000)
  13. Sterile Drug Products Produced by Aseptic Processing PDF document (Issued 6/1987, Posted 3/2/1998)

Compliance (Draft)

  1. Current Good Manufacturing Practice for Medical Gases [Word] or [PDF] (Posted 5/6/2003)
  2. Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24) Draft released for comment 3/30/2000 (5/12/2000)
  3. Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (Issued 9/30/1998, Posted 9/30/1998)
  4. Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients PDF document (Issued 4/17/1998, Posted 4/17/1998)
  5. PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML] or [PDF] (Issued 3/29/2002, Posted 3/29/2002)
  6. Part 11, Electronic Records; Electronic Signatures -- Scope and Application [Word] or [PDF] (Issued 2/2003, Posted 2/20/2003)
  7. Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics [HTML] or [PDF] (Issued 6/2002, Posted 6/27/2002)

Electronic Submissions

  1. Providing Regulatory Submissions in Electronic Format — ANDAs [HTML] or [PDF] (Issued 6/2002, Posted 6/27/2002)
  2. Regulatory Submissions in Electronic Format; General Considerations PDF document (Issued 1/1999, Posted 1/27/1999)
  3. Regulatory Submissions in Electronic Format; New Drug Applications PDF document (Issued 1/1999, Posted 1/27/1999)

Example of an Electronic New Drug Application Submission (Posted 2/17/1999).

Electronic Submissions Draft

  1. Part 11, Electronic Records; Electronic Signatures -- Scope and Application [Word] or [PDF] (Issued 2/2003, Posted 2/20/2003)
  2. Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports [HTML] or [PDF] (Issued 5/2001, Posted 5/3/2001)
  3. Providing Regulatory Submissions in Electronic Format - Postmarketing Periodic Adverse Drug Experience Reports [HTML] or [Word] or [PDF] (Posted 6/23/3003)
  4. Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling [HTML] or [PDF] (Issued 1/2001, Posted 1/30/2001)

Generics

  1. 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day [Word] or [PDF] (Issued 7/2003, Posted 7/31/2003)

  2. Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs [HTML] or [PDF] (Posted 12/12/2000)
  3. ANDA's: Impurities in Drug Substances [HTML] or [PDF]  (Issued 11/1999, Posted 12/2/1999)
  4. Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF]  (Posted 3/27/2000)
  5. 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 document (Posted 3/2/1998)
  6. 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 document (Posted 3/2/1998)
  7. 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 document (Posted 3/2/1998)
  8. Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters PDF document (Posted 3/2/1998)
  9. Letter on the provision of new procedures and policies affecting the generic drug review process PDF document (Posted 3/2/1998)
  10. 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 document (Posted 3/2/1998)
  11. 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 document (Posted 3/2/1998)
  12. 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 document (Posted 3/2/1998)
  13. Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements PDF document (Posted 3/2/1998)
  14. Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications [PDF] (Issued 12/2001, Posted 12/20/2001)
  15. Organization of an ANDA PDF document (Issued 2/1999, 3/2/1999)
  16. Revising ANDA Labeling Following Revision of the RLD Labeling [HTML] or [PDF] (Issued 4/26/2000, 4/26/2000)
  17. Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products [HTML] or [PDF]  (Issued 12/1999, Posted 2/3/2000)
  18. Variations in Drug Products that May Be Included in a Single ANDA PDF document (Issued 12/1998, Posted 1/26/1999)

Generics (Draft)

  1. ANDAs: Impurities in Drug Products PDF document (Issued 12/1998, Posted 1/5/1999)
  2. Content and Format of an Abbreviated New Drug Application (ANDA) - Positron Emission Tomography (PET) Drug Products With specific information for ANDAs for Fludeoxyglucose F18 Injection (Issued 4/1997, Posted 4/23/1997) PDF document
  3. Handling and Retention of BA and BE Testing Samples PDF document (Issued 8/2002, Posted 8/20/2002)

Good Review Practices (GRPs)

  1. Pharmacology/Toxicology Review Format [PDF] (Posted 5/9/2001) PDF document

Good Review Practices (GRPs) (Draft)

  1. Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review PDF document   (11/1996)

Industry Letters

  1. 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 document (Posted 3/2/1998)
  2. 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 document (Posted 3/2/1998)
  3. 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 document (Posted 3/2/1998)
  4. Implementation of the Drug Price Competition and Patent Term Restoration Act.   Preliminary Guidance PDF document (Posted 3/2/1998)
  5. Implementation Plan USP injection nomenclature PDF document (Posted 3/2/1998)
  6. 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 document (Posted 3/2/1998)
  7. 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 document (Posted 3/2/1998)
  8. Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) PDF document (Posted 3/2/1998)
  9. Third of a series of letters regarding the implementation of the Act PDF document (Posted 3/2/1998)
  10. Year 2000 Letter from Dr. Janet Woodcock (10/19/98)

International Conference on Harmonisation

Safety

  1. S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals PDF document
  2. S1B Testing for Carcinogenicity of Pharmaceuticals PDF document (Issued 2/28/1998, Posted 3/24/1998)
  3. S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals PDF document
  4. S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes PDF document (Issued 12/4/1997, Posted 12/11/1997)
  5. S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals PDF document
  6. S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals PDF document (Issued 11/21/1997, Posted 5/4/1998)
  7. S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies PDF document
  8. S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies PDF document
  9. S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) [PDF] or [Text] Posted 6/25/99
  10. S5A Detection of Toxicity to Reproduction for Medicinal Products PDF document (Issued 9/1994, Posted 4/23/1997)
  11. S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility PDF document
  12. S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals PDF document (Issued 11/1997, Posted 11/18/1997)
  13. S7A Safety Pharmacology Studies for Human Pharmaceuticals [HTML] or [PDF] (Issued 7/2001, Posted 7/12/2001)

 

Joint Safety/Efficacy (Multidisciplinary)

  1. M2 eCTD: Electronic Common Technical Document Specification [PDF] (Posted 4/1/2003)
  2. M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals PDF document (Issued 11/1997, Posted 11/25/1997)
  3. M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (Posted 10/15/2001)

Efficacy

  1. E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions PDF document
  2. E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting PDF document
  3. E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports (Issued 1/15/1998, Posted 1/15/1998) PDF document
  4. E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs PDF document (Issued 5/19/1997, Posted 3/19/1998)
  5. E3 Structure and Content of Clinical Study Reports PDF document
  6. E4 Dose-Response Information to Support Drug Registration PDF document
  7. E5 Ethnic Factors in the Acceptability of Foreign Clinical Data PDF document (Issued 6/10/1998, Posted 6/10/1998)
  8. E6 Good Clinical Practice: Consolidated Guideline PDF document Spanish Version (Issued 5/9/1997, Posted 3/19/1998)
  9. E7 Studies in Support of Special Populations: Geriatrics PDF document
  10. E8 General Considerations for Clinical Trials PDF document (Issued 12/1997, Posted 12/17/1997)
  11. E9 Statistical Principles for Clinical Trials PDF document (9/1/1998)
  12. E 10 Choice of Control Group and Related Issues in Clinical Trials [HTML] or [PDF] (Issued 5/2001, Posted 5/11/2001)
  13. E11 Clinical Investigation of Medicinal Products in the Pediatric Population [Acrobat] (Issued 12/2000, Posted 12/14/2000)

Quality

  1. Q1A(R) Stability Testing of New Drug Substances and Products [HTML] or [PDF] (Posted 11/6/2001)
  2. Q1B Photostability Testing of New Drug Substances and Products [HTML] or [PDF] (Issued 11/1996, Reposted 7/7/1998)
  3. Q1C Stability Testing for New Dosage Forms PDF document (Issued 5/9/1997, Posted 3/19/1998)
  4. Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products [Word] or [PDF] (Issued 1/2003, Posted 1/15/2003)
  5. Q2A Text on Validation of Analytical Procedures PDF document
  6. Q2B Validation of Analytical Procedures: Methodology PDF document (Issued 5/19/1997, Posted 3/19/1997)
  7. Q3A Impurities in New Drug Substances [Word] or [PDF] (Issued 2/10/2003, Posted 2/10/2003)
  8. Q3B Impurities in New Drug Products or Adobe Acrobat version PDF document (Issued 5/19/1997, Reposted 7/7/1998)
  9. Q3C Impurities: Residual Solvents or Adobe Acrobat version PDF document (Issued 12/24/1997, Posted 12/30/1997)
    Q3C Tables and List or Adobe Acrobat version PDF document (Posted 10/2/2001).
    Appendix 4, Appendix 5, and Appendix 6 (Appendices were issued with the Q3C draft guidance documents)
    Maintenance Procedures for Updating (Posted 2/11/2002)
  10. Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (Posted 9/1998)
  11. Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products PDF document
  12. Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products PDF document
  13. Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability PDF document (Issued 9/21/1998, Posted 9/21/1998)
  14. Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. [Text] or [PDF] (12/29/2000)
  15. Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products [PDF] (Issued 8/1999, Posted 12/14/2001)
  16. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients [HTML] or [PDF] (Issued 8/2001, Posted 9/24/2001]

International Conference on Harmonisation (Draft)

Efficacy

  1. E2C Addendum to ICH E2C Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs PDF document  (Issued 9/2002, Posted 12/27/2002)                
  2. Principles for Clinical Evaluation of New Antihypertensive Drugs.  Optional Format: PDF. (Issued 8/2000, Posted 8/8/2000)

Joint Safety/Efficacy (Multidisciplinary) (Draft)

  1. Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [PDF]
  2. M4 Common Technical Document--Quality: Questions and Answers/Location Issues [HTML] or [PDF] or [WORD] (Issued 9/12/2002, Posted 12/30/2002)

Quality

  1. Q3B(R) Impurities in New Drug Products  [Text] or [PDF] (Issued 7/2000, Posted 7/19/2000)
  2. Q1E Evaluation of Stability Data  [HTML] or [PDF] (Issued 6/2002, Posted 6/13/2002)
  3. Q1F Stability Data Package for Registration in Climatic Zones III and IV [HTML] or [PDF] (Issued 6/2002, Posted 6/13/2002)

Safety 

  1. S7B Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals  [HTML] or [PDF] (Issued 6/2002, Posted 6/13/2002)

Investigational New Drug Applications

  1. Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs PDF document

Labeling  

The unlinked guidance's below have been withdrawn.  See Federal Register Notice from July 5, 2002 : [Text] or [PDF]

  1. Acetaminophen, Aspirin and Codeine Phosphate Tablets and Acetaminophen, Aspirin and Codeine Phosphate Capsules 
  2. Acetaminophen and codeine Phosphate Oral Solution and oral suspension  (Issued 12/1993, Posted 7/11/1997)
  3. Alprazolam Tablets  or WordPerfect 6.x Version (Issued 8/1996, Posted 8/21/1997)
  4. Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP  (Issued 9/1997, Posted 10/16/1997)
  5. Amlodipine Besylate Tablets  (Issued 9/1997, Posted 10/15/1997)
  6. Astemizole Tablets  (Issued 9/1997, Posted 10/15/1997)
  7. Atenolol Tablets  or WordPerfect 6.x Version (Issued 8/1997, Posted 8/21/1997)
  8. Butalbital, Acetaminophen and Caffeine Tablets USP, Butalbital, Acetaminophen and Caffeine Capsules USP  (Issued 9/1997, Posted 10/16/1997)
  9. Butalbital, Acetaminophen, Caffeine and Hydrocodone Bitartrate Tablets  (Issued 9/1997, Posted 10/16/1997)
  10. Butorphanol Tartrate Injection USP 
  11. Captopril and Hydrochlorothiazide Tablets, USP 
  12. Captopril Tablets  (Issued 2/1995, Posted 7/11/1997)
  13. Carbidopa and Levodopa Tablets USP 
  14. Cimetidine Hydrochloride Injection  (Issued 9/1995, Posted 7/11/1997)
  15. Cimetidine Tablets, USP 
  16. Cisapride Oral Suspension  (Issued 9/1997, Posted 10/16/1997)
  17. Cisapride Tablets  (Issued 9/1997, Posted 10/20/1997)
  18. Clindamycin Phosphate Injection USP  (Revised 9/1998, Posted 10/15/1998)
  19. Content and Format for Geriatric Labeling [HTML] or [PDF] (Issued 10/2001, Posted 10/4/2001)
  20. Diclofenac Sodium Delayed-release Tablets 
  21. Diltiazem Hydrochloride Extended-release Capsules 
  22. Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP 
  23. Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP 
  24. Fludeoxyglucose F18 Injection  (Issued 1/1997, Posted 3/1/1997)
  25. Flurbiprofen Tablets USP 
  26. Fluvoxamine Maleate Tablets  (Issued 9/1997, Posted 10/20/1997)
  27. Gentamicin Sulfate Ophthalmic Solution USP and Gentamicin Sulfate Ophthalmic Ointment USP 
  28. Heparin Sodium Injection, USP 
  29. Hydrocodone Bitartrate and Acetaminophen Tablets USP 
  30. Indomethacin Capsules, USP 
  31. Itraconazole Capsules  (Isssued 9/1998, Posted 10/15/1998)
  32. Leucovorin Calcium for Injection  (Issued 7/1996, Posted 7/11/1997)
  33. Leucovorin Calcium Tablets USP  (Issued 7/1996, Posted 7/11/1996)
  34. Medroxyprogesterone Acetate Tablets, USP  (Revised 9/1998, Posted 10/15/1998)
  35. Metaproternol Sulfate Inhalation Solution USP 
  36. Metaproterenol Sulfate Syrup, USP 
  37. Metaproterenol Sulfate Tablets, USP 
  38. Metoclopramide Tablets USP and Metoclopramide Oral Solution USP 
  39. Naproxen Sodium Tablets USP  (Issued 9/1997, Posted 10/16/1997)
  40. Naproxen Tablets USP  (Issued 9/1997, Posted 10/16/1997)
  41. Paclitaxel Injection  (Issued 9/1997, Posted 10/15/1997)
  42. Quinidine Sulfate Tablets USP  (Issued 10/1995, Posted 7/11/1997)
  43. Ranitidine Tablets USP 
  44. Risperidone Oral Solution  (Issued 9/1997, Posted 10/15/1997)
  45. Risperidone Tablets  (Issued 9/1997, Posted 10/15/1997)
  46. Sulfacetamide Sodium Ophthalmic Solution USP and Sulfacetamide Sodium Ophthalmic Ointment USP 
  47. Sulfacetamide Sodium and Prednisolone Acetate 
  48. Sulfamethoxazole and Trimethoprim Tablets USP and Sulfamethoxazole and Trimethoprim Oral Suspension USP 
  49. Theophylline 
  50. Theophylline Intravenous Dosage Forms  (Issued 9/1/1995, Posted 7/11/1997)
  51. Tobramycin Sulfate Injection USP 
  52. Venlafaxine Hydrochloride Tablets (Issued 10/1997, Posted 12/23/1997)
  53. Verapamil Hydrochloride Tablets 
  54. Zolpidem Tartrate Tablets  (Issued 9/1997, Posted 10/15/1997)

Labeling (Draft)

  1. Clinical Studies Section of Labeling for Prescription Drugs and Biologics-- Content and Format [HTML] or [PDF] (Issued 7/2001, Posted 7/9/2001)
  2. Combined Oral Contraceptives - Labeling for Healthcare Providers and Patients [HTML] or [PDF] (Issued 7/2000, Posted 7/7/2000)
  3. Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics [HTML] or [PDF] (Issued 6/2000, Posted 6/20/2000)
  4. Draft Guidance for Industry on Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) PDF document (Issued 6/1998, Posted 7/20/98)
  5. Labeling Guidance for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Prescribing Information for Health Care Providers and Patient Labeling [Word] or [PDF] (Posted 1/31/2003)
  6. Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications [HTML] or [PDF] (Issued 10/2000, Posted 10/25/2000)

Microbiology

  1. Format and Content of the Microbiology Section of an Application* PDF document

Modernization Act of 1997

  1. Changes to an Approved NDA or ANDA [HTML] or [PDF] (Issued 11/1999, Posted 11/19/1999)
  2. Classifying Resubmissions in Response to Action Letters PDF document (Issued 5/14/1998, Posted 5/14/1998)
  3. Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act PDF document or Word Version (Issued 11/1998, Posted 11/20/1998)
  4. Fast Track Drug Development Programs – Designation, Development, and Application Review PDF document
    Appendix 2 PDF Doc;  Appendix 3 PDF Doc consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 PDF Doc [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)
  5. Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] (Issued 2/2000, Posted 3/6/2000)
  6. Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] (Issued 2/2000, Posted 3/6/2000)
  7. Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees Wordperfect or Acrobat Version (Issued 10/1998, Posted 11/02/98)
  8. Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements PDF document (Issued 7/1998, Posted 7/20/98)
  9. Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [HTML] or [PDF] (Issued 3/2002, Posted 3/18/2002)
  10. National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs PDF document (Issued 4/1998, Posted 5/5/1998)
  11. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products PDF document (Issued 5/14/1998, Posted 5/14/1998)
  12. Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF] (Issued 9/1999, Posted 10/4/1999)
  13. Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act PDF document (Revised 5/1998, Posted 6/12/1998)
  14. Standards for Prompt Review of Efficacy Supplements PDF document (Issued 5/15/1998, Posted 5/15/1998)
  15. Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1998, Posted 9/15/98) PDF document
  16. Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  [HTML] or [PDF] (Issued 10/2000, Posted 10/25/2000
  17. Women and Minorities Guidance Requirements PDF document (Issued 7/20/1998, Posted 11/25/1998)

Modernization Act of 1997 (Draft)

  1. Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank [HTML] or PDF (Issued 3/2000, Posted 3/28/2000)

  2. PET Drug Applications - Content and Format for NDAs and ANDAs [HTML] or [PDF] (Issued 3/7/2000, Posted 3/7/2000)

  3. Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML] or [PDF] (Posted 4/4/2001) 

Over-the-Counter (OTC) Guidances

  1. Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) PDF document (Posted 3/2/1998)
  2. General Guidelines for OTC Combination Products PDF document (Posted 3/2/1998)
  3. Labeling OTC Human Drug Products Using a Column Format [HTML] or [PDF] (Issued 12/2000, Posted 12/18/2000)
  4. Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs [Word] or [PDF] 
    Example Drug Facts Labels
  5. Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) PDF document (Posted 3/2/1998)

Over-the-Counter (OTC) Draft

  1. Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals [HTML] or [PDF] (Issued 12/2000, Posted 12/18/2000)
  2. Labeling OTC Human Drug Products Updating Labeling in ANDAs [HTML] or [PDF] (2/21/2001)

Pharmacology/Toxicology

  1. Carcinogenicity Study Protocol Submissions [HTML] or [PDF] (Issued 5/22/2002)
  2. Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products [HTML] or [PDF]
  3. Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* PDF document (Posted 3/2/1998)
  4. Immunotoxicology Evaluation of Investigational New Drugs [Word] or [PDF] (Issued 10/2002, Posted 10/31/2002)
  5. 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
  6. Photosafety Testing [Word] or [PDF] (Posted 5/7/2003)
  7. 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 document (Posted 3/2/1998)
  8. Single Dose Acute Toxicity Testing for Pharmaceuticals PDF document

Pharmacology/Toxicology Draft

  1. Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers [Word] or [PDF] (Issued 1/2003, Posted 1/15/2003)
  2. Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities [PDF] (Issued 11/2001, Posted 11/9/2001)
  3. Nonclinical Safety Evaluation of Pediatric Drug Products [Word] or [PDF] (Issued 1/2003, Posted 1/31/2003)
  4. Nonclinical Studies for Development of Pharmaceutical Excipients [Word] or [PDF] (Issued 10/2002, Posted 10/2/2002)
  5. Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals [HTML] or [PDF] (Issued 5/2001, Posted 5/7/2001)

Procedural

  1. 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act PDF document (Issued 6/1998, Posted 6/22/1998)
  2. Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF]  (Posted 3/27/2000)
  3. 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] (Issued 11/1999, Posted 11/29/1999)
  4. Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy [Word] or [PDF] (Posted 6/3/2003)
  5. Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act PDF document or Word Version (Issued 11/1998, Posted 11/20/1998)
  6. Fast Track Drug Development Programs – Designation, Development, and Application Review PDF document
    Appendix 2 PDF Doc;  Appendix 3 PDF Doc consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 PDF Doc [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)
  7. Financial Disclosure by Clinical Investigators (3/27/2001)
  8. Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] (Issued 2/2000, Posted 3/6/2000)
  9. Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] (Issued 2/2000, Posted 3/6/2000)
  10. Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations [HTML] or [PDF] (Revised 6/2003)
  11. Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees Wordperfect or Acrobat Version (Issued 10/1998, Posted 11/02/98)
  12. Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements PDF document (Issued 7/1998, Posted 7/20/98)
  13. Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [HTML] or [PDF] (Issued 3/2002, Posted 3/18/2002)
  14. Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act [HTML] or [PDF] (Issued 11/2001)
  15. Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications [HTML] or [PDF] (Issued 7/2001, Posted 7/12/2001)
  16. National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs PDF document (Issued 4/1998, Posted 5/5/1998)
  17. Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies [HTML] or [PDF] (Issued 12/2001, Posted 12/10/2001)
  18. Reduction of Civil Money Penalties for Small Entities (Issued 3/20/2001)
  19. Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF] (Issued 9/1999, Posted 10/4/1999)
  20. Refusal to File PDF document (Issued 7/12/1993, Posted 11/26/99)
  21. Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act PDF document (Revised 5/1998, Posted 6/12/1998)
  22. Special Protocol Assessment [HTML] or [PDF] (Issued 5/2002, Posted 5/16/2002)
  23. Standards for Prompt Review of Efficacy Supplements PDF document (Issued 5/15/1998, Posted 5/15/1998)

Procedural Draft

  1. Applications Covered by Section 505(b)(2) [HTML] or [PDF] or [Word] (Issued 10/1999, Posted 12/7/1999)
  2. Collection of Race and Ethnicity Data in Clinical Trials [Word] or [PDF] (Issued 1/2003, Posted 1/23/2003)
  3. Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA [Word] or [PDF] (Posted 6/12/2003)
  4. Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA [Word] or [PDF] (Posted 6/12/2003)
  5. 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] (Issued 12/1999, Posted 12/22/1999)
  6. Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees [HTML]or [PDF]  (2/14/2002)
  7. Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution [HTML] or [PDF] (5/14/2001)
  8. Good Review Management Principles for PDUFA Products [PDF] (Posted 7/28/2003)
  9. Guidance for Clinical Trial Sponsors - On the Establishment and Operation of Clinical Trial Data Monitoring Committees PDF document (Posted 7/10/2003)
  10. Guidance for Federal Agencies and State and Local Governments Potassium Iodide Tablets Shelf Life Extension [HTML] - [Word] - [PDF] (Posted 4/1/2003)
  11. Guidance for Clinical Trial Sponsors - On the Establishment and Operation of Clinical Trial Data Monitoring Committees PDF document (Posted 7/10/2003)
  12. Independent Consultants for Biotechnology Clinical Trial Protocols [HTML] or [PDF] (Posted 5/7/2003)
  13. PET Drug Applications - Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)
  14. Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines PDF document (Issued 3/2001, Posted 3/9/2001)
  15. Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML] or [PDF] (Posted 4/4/2001)
  16. Submitting Debarment Certification Statements PDF document (Issued 10/2/98, Posted 10/2/98)
  17. Submitting Marketing Applications According to the ICH/CTD Format: General Considerations [PDF] (Issued 9/2001, Posted 9/5/2001) 
  18. The Use of Clinical Holds Following Clinical Investigator Misconduct  PDF document (Issued 4/2002, Posted 8/26/2002)

Small Entity Compliance Guides

  1. Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide [PDF]  (Posted 11/7/2001) 

User Fees

  1. Classifying Resubmissions in Response to Action Letters PDF document (Issued 5/14/1998, Posted 5/14/1998)
  2. Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act [HTML] or [PDF] (Issued 6/1999, Posted 6/25/99)
  3. Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act [HTML] or [PDF] (Issued 11/2001)
  4. Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  [HTML] or [PDF] (Issued 10/2000, Posted 10/25/2000)

User Fees (Draft)

  1. Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees [PDF] (2/21/2001)

Also see Current Good Manufacturing Practice Regulations

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

[Accessibility]

 

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