|
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
, also known as
PDF. The free upgrade to Adobe
Acrobat 5.0 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.
[Accessibility]
- Aerosol Steroid
Product Safety Information in Prescription Drug Advertising and Promotional
Labeling (Issued 12/1997, Posted 1/12/1998)
- Consumer-Directed Broadcast Advertisements [HTML] or [PDF] (Issued 8/1999,
Posted 8/6/1999)
Questions and
Answers (Posted 8/6/1999)
- Industry-Supported Scientific and Educational Activities [HTML] or [PDF] (Issued
12/3/1997, Posted 12/4/1997)
- Accelerated
Approval Products: Submission of Promotional Materials
(Posted
3/26/1999)
- Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements [Word] or [PDF]
(Posted 2/4/2004)
- Labeling Example [Word] or [PDF]
- Labeling Example; Consumer-Friendly Version [Word]
or [PDF]
- Consumer-Directed Broadcast Advertising of Restricted
Devices [HTML]
or [PDF] (Issued
1/26/2004, Posted 2/4/2004)
- Help-Seeking and Other Disease Awareness
Communications by or on Behalf of Drug and Device Firms [Word]
or [PDF] (Issued 1/26/2004, Posted 2/4/2004)
- Product Name
Placement, Size, and Prominence in Advertising and Promotional Labeling
(Issued 1/1999, Posted 3/12/1999)
- Promoting Medical
Products in a Changing Healthcare Environment; I. Medical Product Promotion by
Healthcare Organizations or Pharmacy Management Companies (PBMs)
(Issued 12/1997. Posted 1/5/1998)
- Bioanalytical Method Validation [HTML] or [PDF] (Issued 5/2001,
Posted 5/22/2001)
- Bioavailability and Bioequivalence Studies for Orally Administered Drug
Products - General Considerations [Word] or [PDF]
(Issued 3/2003, Posted 3/19/2003)
- Cholestyramine
Powder in Vitro Bioequivalence (Intermin Guidance)
- Clozapine Tablets
in Vivo Bioequivalence and in Vitro Dissolution Testing
(Issued 11/15/1996,
Reposted 10/15/1998)
- Corticosteroids,
Dermatologic (topical) In Vivo
(Issued 6/2/1995, Posted 3/6/1998)
- Dissolution Testing
of Immediate Release Solid Oral Dosage Forms
or WordPerfect 6.x
Version (Issued 8/1997, Posted 8/25/1997)
- Extended Release
Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In
Vivo Correlations
(Issued 9/1997, Posted 9/26/1997)
- Food-Effect Bioavailability and Fed Bioequivalence Studies [Word]
or [PDF] (Issued 12/2002, Posted 1/30/2003)
- Metaproterenol
Sulfate and Albuterol Metered Dose Inhalers In Vitro
(Issued 6/27/1989,
Posted 3/2/1998)
- Phenytoin/Phenytion
Sodium (capsules, tablets, suspension) In Vivo Bioequivalence and In Vitro
Dissolution Testing
(Issued 3/4/1994, Posted 3/2/1998)
- Potassium Chloride
(slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro
Dissolution Testing
(Revised 6/6/1994, Posted 6/22/1998)
- Statistical Approaches to Establishing Bioequivalence [HTML] or [PDF] (Issued 2/2001,
Posted 2/1/2001)
- 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)
- Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal
Sprays for Local Action [Word] or [PDF]
(Posted 4/2/2003)
- Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing
[Word] or [PDF] (Posted
12/29/2003)
- 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)
- In Vivo
Bioequivalence Studies Based on Population and Individual Bioequivalence
Studies (Issued 12/10/1997, Posted 12/10/1997) Bioequivalence Studies Data and Detailed Statistical
Methodology (Posted 3/2/1998)
- Potassium Chloride Modified-Release Tablets and Capsules: In Vivo
Bioequivalence and In Vitro Dissolution Testing
(Issued 8/2002, Posted 8/6/2002)
CGMPs (Pharmaceutical CGMPs for the 21st Century)
-
Questions and Answers on Current Good
Manufacturing Practices (cGMP) for Drugs (Posted 8/4/2004)
- Part 11, Electronic Records; Electronic Signatures Scope and Application
[HTML] [PDF] [Word]
(Posted 9/3/2003)
- PAT A Framework for Innovative Pharmaceutical Development,
Manufacturing, and Quality Assurance [HTML] [PDF]
[Word] (posted 9/29/2004)
- Sterile Drug Products Produced by Aseptic Processing Current Good
Manufacturing Practice [HTML] [PDF]
[Word] Posted 9/29/2004
CGMPs (Pharmaceutical CGMPs
for the 21st Century) -- Draft
- Comparability Protocols - Protein Drug Products and Biological Products -
Chemistry, Manufacturing, and Controls Information [HTML] [PDF]
[Word] (Posted 9/3/2003)
- Current Good Manufacturing Practice for Combination Products [HTML]
[PDF] [Word] (Posted
9/29/2004)
- Formal Dispute Resolution: Scientific and Technical Issues Related to
Pharmaceutical CGMP [HTML] [PDF]
[Word] (Posted 9/3/2003)
- Powder Blends and Finished Dosage Units Stratified In-Process Dosage
Unit Sampling and Assessment [HTML] [PDF] or [Word]
(Issued 11/2003, Posted 11/6/2003)
- Revised Attachments [Word] or [PDF]
(Issued 11/2003, Posted 11/21/2003)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing
Practice Regulations [HTML] [PDF]
[Word] (Posted 9/29/2004)
- 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)
- Botanical Drug Products [HTML] or [PDF] or [Word]
(Issued 6/2004, Posted 6/9/2004)
- Changes to an
Approved Application for Specified Biotechnology and Specified Synthetic
Biological Products
(Issued 7/1997, Posted 7/28/1997)
- Changes to an Approved NDA or ANDA [Word] or [PDF] (Issued
4/2004,
Posted 4/7/2004)
- Changes to an Approved NDA or ANDA: Questions and Answers [HTML] or [PDF] (Issued 1/2001,
Posted 1/22/2001)
- Container Closure Systems for Packaging Human Drugs and Biologics [HTML] or [PDF] (Issued 5/1999,
Posted 7/6/1999)
- Container Closure Systems for Packaging Human Drugs and Biologics --
Questions and Answers [PDF] (Issued 5/2002,
Posted 5/10/2002)
- Demonstration of
Comparability of Human Biological Products, Including Therapeutic
Biotechnology-derived Products
- Development of New
Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996)
- Drug Master Files
(9/1/1989)
Current DMF Information
(e.g. lists, addresses, guidances, etc.)
- Drug Master Files for Bulk Antibiotic Drug Substances [PDF] or [Word] (Issued 11/1999,
Posted 11/26/1999)
- Environmental
Assessment of Human Drug and Biologics Applications
(Issued 7/1998,
Posted 7/24/98)
- Format and Content
of the Chemistry, Manufacturing and Controls Section of an Application*
(Issued 2/1987, Posted 3/2/1998)
- Format and Content for
the CMC Section of an Annual Report (9/1/1994)
- INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and
Controls Information [Word] or [PDF]
(Posted 5/20/2003)
- IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and
Controls Information [HTML] or [PDF] (Issued 5/2001,
Posted 6/4/2001)
- Monoclonal Antibodies Used as Reagents in Drug Manufacturing [HTML] or [PDF] (Issued 3/2001,
Posted 3/28/2001)
- Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML]
or [PDF] (Issued 7/2002, Posted 7/3/2002)
- NDAs: Impurities in Drug Substances [HTML] or [PDF] (Issued 2/2000,
Posted 2/24/2000)
- PAC-ATLS:
Postapproval Changes - Analytical Testing Laboratory Sites
(Issued 4/28/1998,
Posted 4/28/1998)
-
The
Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by
Bovine Spongiform Encephalopathy (BSE) (12/20/2000)
- 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
- SUPAC-IR Questions
and Answers about SUPAC-IR Guidance (2/18/1997)
- SUPAC-IR/MR:
Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing
Equipment Addendum
(Issued 1/1999, Posted 2/25/1999)
- 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
(Issued 10/6/1997, Posted 10/6/1997)
- 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
(Issued 5/1997; Posted 6/16/1997)
- Reviewer Guidance,
Validation of Chromatographic Methods
- Submission
Documentation for Sterilization Process Validation in Applications for Human
and Veterinary Drug Products
- Submission of
Chemistry, Manufacturing, and Controls Information for Synthetic Peptide
Substances
- Submitting Documentation for the Manufacturing of and Controls for Drug
Products* [HTML]
or [PDF] (Issued
2/1987, Posted 3/2/1998)
- Submitting
Documentation for the Stability of Human Drugs and Biologics*
(Issued
2/1987, Posted 3/2/1998)
- Submitting Samples
and Analytical Data for Methods Validation
- Submitting
Supporting Documentation in Drug Applications for the Manufacture of Drug
Substances
- Analytical
Procedures and Methods Validation. Optional format: PDF. (Issued 8/2000,
Posted 8/30/2000)
- Comparability Protocols -- Chemistry, Manufacturing, and Controls
Information [Word] or [Acrobat]
(Issued 2/2003, Posted 2/20/2003)
- Drugs, Biologics, and
Medical Devices Derived from Bioengineered Plants for Use in Humans and
Animals (Posted
9/11/2003)
- Drug Product: Chemistry, Manufacturing, and Controls
Information (Issued 1/2003, Posted 1/28/2003)
- Drug Substance: Chemistry, Manufacturing, and Controls Information [Word]
or [PDF] (Issued 1/2004, Posted 1/6/2004)
-
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations [HTML] or [PDF]
(7/24/1999)
- 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)
- Liposome Drug Products: Chemistry, Manufacturing,
and Controls; Human Pharmacokinetics and Bioavailability; and Labeling
Documentation. (Issued 7/2002, Posted 8/20/2002)
- Stability Testing
of Drug Substances and Drug Products
(Issued 6/5/1998, Posted 6/8/1998)
- SUPAC-SS:
Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
(Issued
12/1998, Posted 1/5/1999)
- Antiretroviral Drugs Using Plasma HIV RNA Measurements Clinical
Considerations for Accelerated and Traditional Approval [Word]
or [PDF] (Issued 10/2002, Posted 10/31/2002)
- Clinical Development and Labeling of Anti-Infective Drug Products [HTML] or [PDF] (Issued
10/1992, Posted 3/2/1998, Revised 2/12/2001)
- Clinical
Evaluation of Anti-Infective Drugs (Systemic)
(Issued 9/77, Posted
3/2/1998)
- Preclinical
Development of Antiviral Drugs
- Acute Bacterial
Exacerbation of Chronic Bronchitis Developing Antimicrobial Drugs for
Treatment (Issued 7/22/1998, Posted 7/22/1998)
- Acute Bacterial
Meningitis Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Acute Bacterial
Sinusitis Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Acute or Chronic
Bacterial Prostatitis Developing Antimicrobial Drugs for Treatment
(Issued
7/22/1998, Posted 7/22/1998)
- Acute Otitis Media
Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Bacterial Vaginosis
Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs
for Treatment [HTML] or [PDF] (Issued 10/1999,
Posted 10/18/1999)
- Community-Acquired
Pneumonia Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Complicated Urinary Tract Infections and Pyelonephritis Developing
Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
[HTML] or [PDF]
- Developing
Antimicrobial Drugs General Considerations for Clinical Trials
(Issued
7/22/1998, Posted 7/22/1998) [Main Document]
- Empiric Therapy of
Febrile Neutropenia Developing Antimicrobial Drugs for Treatment
(Issued
7/22/1998, Posted 7/22/1998)
- Evaluating
Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug
Products (2/18/1997)
- Inhalational Anthrax (Post Exposure) -- Developing
Antimicrobial Drugs (Issued 3/15/2002, Posted 3/15/2002) [HTML]
or [PDF]
- Lyme Disease
Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted 7/22/1998)
- Nosocomial
Pneumonia Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Secondary Bacterial
Infections of Acute Bronchitis Developing Antimicrobial Drugs for
Treatment (Issued 7/22/1998, Posted 7/22/1998)
- Streptococcal
Pharyngitis and Tonsillitis Developing Antimicrobial Drugs for Treatment
(Issued
7/22/1998, Posted 7/22/1998)
- Uncomplicated and
Complicated Skin and Skin Structure Infections Developing Antimicrobial
Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
- Uncomplicated
Gonorrhea Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Uncomplicated
Urinary Tract Infections Developing Antimicrobial Drugs for Treatment
(Issued
7/22/1998, Posted 7/22/1998)
- Vaccinia Virus Developing Drugs to Mitigate Complications from Smallpox
Vaccination [Word] or [PDF]
(Posted 3/8/2004)
- Vulvovaginal
Candidiasis Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted
7/22/1998)
- Acceptance of Foreign Clinical Studies [HTML] or [PDF] (Posted 3/12/2001)
- Available Therapy [HTML] or [Word] or [PDF]
(Posted 7/22/2004)
- Calcium DTPA and Zinc DTPA Drug Products - Submitting a
New Drug Application [HTML] or [Word] or [PDF]
(Posted 8/13/2004)
- Cancer Drug and Biological Products - Clinical Data in Marketing
Applications [HTML]
or [PDF] (Posted
10/11/2001)
- 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]
- Clinical
Development Programs for MDI and DPI Drug Products
(Issued 9/19/1994,
Posted 3/2/1998)
- Clinical
Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003,
Federal Register Notice)
- Clinical
Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal
Register notice.)
- Clinical
Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and
children)
- Clinical
Evaluation of Antianxiety Drugs
(Issued 9/77, Posted 3/2/1998)
- Clinical
Evaluation of Antidepressant Drugs
(Issued 9/77, Posted 3/2/1998)
- Clinical
Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal
Register notice.)
- Clinical
Evaluation of Antiepileptic Drugs (adults and children)
(Issued 1/1981,
Posted 3/2/1998)
- Clinical
Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per
July 20, 2004, Federal Register notice.)
- Clinical
Evaluation of General Anesthetics
(Issued 5/1982, Posted 3/2/1998)
- Clinical
Evaluation of Hypnotic Drugs
(Issued 9/77, Posted 3/2/1998)
- Clinical
Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal
Register notice.)
- Clinical
Evaluation of Local Anesthetics
(Posted 3/2/1998)
- Clinical
Evaluation of Psychoactive Drugs in Infants and Children
(Posted 3/2/1998)
- Clinical
Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal
Register notice.)
- Content and Format
for Pediatric Use Supplements
- Content and Format of
Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic, Biotechnology-derived Products
- Developing Medical Imaging Drug and Biological Products
- Part 1: Conducting Safety Assessments [HTML]
or [Word]
or [PDF] (Issued 6/17/2004, Posted 6/17/2004)
- Part 2: Clinical Indications [HTML] or [Word] or [PDF]
(Issued 6/17/2004, Posted 6/17/2004)
- Part 3: Design, Analysis, and Interpretation of Clinical Studies [Word]
or [PDF] (Issued 6/17/2004, Posted 6/17/2004)
- Establishing Pregnancy Exposure Registries [Word]
or [PDF] (Issued 8/2002, Posted 9/20/2002)
- 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)
- FDA Requirements
for Approval of Drugs to Treat Non-Small Cell Lung Cancer
(Posted 3/2/1998)
- FDA Requirements
for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July
20, 2004, Federal Register notice.)
- Format and Content
of the Clinical and Statistical Sections of an Application
(Issued 7/1988,
Posted 5/21/1997)
- Format and Content
of the Summary for New Drug and Antibiotic Applications*
(Issued 2/1987,
Posted 3/2/1998)
- Formatting,
Assembling and Submitting New Drug and Antibiotic Applications*
(Issued
2/1987, Posted 3/2/1998)
- General
Considerations for the Clinical Evaluation of Drugs
- General
Considerations for the Clinical Evaluation of Drugs in Infants and
Children (Issued 9/77, Posted 3/2/1998)
- Guidance for the
Development of Vaginal Contraceptive Drugs (NDA)
(Posted 3/2/1998)
- IND Exemptions for Studies of Lawfully Marketed Drug or Biological
Products for the Treatment of Cancer [Word] or [PDF]
(Revised 1/15/2004, Posted 1/15/2004)
- Integration of Dose-Counting Mechanisms into MDI Drug Products [Word]
or [PDF] (Issued 3/2003, Posted 3/12/2003)
- Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability
Studies and In Vitro Dissolution Testing [HTML] or [PDF] (Issued 2/2001,
Posted 3/8/2001)
- Oncologic Drugs
Advisory Committee Discussion on FDA Requirements for Approval of New Drugs
for Treatment of Ovarian Cancer
(Posted 3/2/1998)
- Oncologic Drugs
Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for
Treatment of Colon and Rectal Cancer
(Posted 3/2/1998)
- Postmarketing
Adverse Experience Reporting for Human Drug and Licensed Biological Products:
Clarification of What to Report
or WordPerfect 6.x
version (Issued 8/27/1997, Posted 8/27/1997)
- Postmarketing
Reporting of Adverse Drug Experiences
(Issued 3/1992, Posted 3/2/1998)
- Preclinical
Development of Immunomodulatory Drugs for Treatment of HIV Infection and
Associated Disorders
(Reposted 1/21/1999)
- Preparation of
Investigational New Drug Products (Human and Animal)
(Issued 11/1992,
Posted 3/2/1998)
- Providing Clinical
Evidence of Effectiveness for Human Drug and Biological Products
(Issued
5/14/1998, Posted 5/14/1998)
- Prussian Blue Drug Products Submitting a New Drug Application [Word]
[PDF] (Issued
1/2003, Posted 2/4/2003)
- Study and
Evaluation of Gender Differences in the Clinical Evaluation of Drugs
(Issued
7/22/1993, Posted 3/2/1998)
- Study of Drugs
Likely to be used in the Elderly
(Issued 11/1989, Posted 3/2/1998)
- Submission of Abbreviated Reports and Synopses in Support of Marketing
Applications [HTML]
or [PDF] (Issued
8/1999, Posted 9/13/1999)
- The Use of Clinical Holds Following Clinical Investigator Misconduct [PDF]
or [Word]
- Allergic Rhinitis: Clinical Development Programs for Drug Products [HTML] or [PDF] (Issued 6/2000,
Posted 6/20/2000)
- Chronic Cutaneous Ulcer and Burn Wounds Developing Products for
Treatment [HTML] or
[PDF] (Issued
6/2000, Posted 6/27/2000)
- 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)
- Clinical Evaluation
of Lipid-Altering Agents (Issued 10/1990, Posted 2/18/1998)
- Clinical Evaluation
of Weight-Control Drugs (9/24/1996, Posted 2/18/1998)
- Clinical Trial Sponsors On the Establishment and Operation of Clinical
Trial Dada Monitoring Committees [HTML]
or [PDF]
(11/15/2001)
- Development and Use of Risk Minimization Action Plans [HTML]
or [PDF]
or [Word] (Issued 5/4/2004, Posted 5/4/2004)
- Development of Parathyroid Hormone for the Prevention and Treatment of
Osteoporosis [HTML]
or [PDF] (Issued
5/2000, Posted 6/13/2000)
- Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants
for Use in Humans and Animals [HTML]or
[PDF] (Issued
9/6/2002)
- 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)
- Evaluation of Human Pregnancy Outcome Data [HTML] or [PDF] (Issued
6/2/1999, Posted 6/8/99)
-
Evaluation of the Effects of
Orally Inhaled and Intranasal Corticosteroids
on Growth in Children [HTML] or [PDF]
(Posted 11/6/2001)
- Exercise-Induced Bronchospasm (EIB) Development of Drugs to Prevent
EIB [PDF] (Issued 2/2002, Posted 2/19/2002)
- Exocrine Pancreatic Insufficiency Drug Products Submitting NDAs [HTML]
or [Word]
or [PDF] (Posted 4/27/2004)
- Female Sexual Dysfunction: Clinical Development of Drug Products for
Treatment [HTML] or
[PDF] (Issued
5/2000, Posted 5/18/2000)
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment [HTML]
or [Word]
or [PDF] (Issued 5/4/2004, Posted 5/4/2004)
- Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors: Exception
from Informed Consent Requirements for Emergency Research (3/31/2000)
- Inhalation Drug Products Packaged in Semipermeable Container Closure
Systems [PDF] (Issued 7/2002, Posted 7/25/2002)
- OTC Treatment of Herpes Labialis with Antiviral Agents [HTML] or [PDF] (Issued 3/8/2000,
Posted 3/8/2000)
- Pediatric Oncology Studies In Response to a Written Request
[HTML] or [PDF] (Issued 6/2000,
Posted 6/19/2000)
- Preclinical and
Clinical Evaluation of Agents Used in the Prevention or Treatment of
Postmenopausal Osteoporosis (Issued 4/1994, Posted 2/18/1998)
- Premarketing Risk Assessment [HTML] or [Word] or [PDF]
(Issued 5/4/2004, Posted 5/4/2004)
- Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a)
and 601.27(a)) [HTML] or [PDF] (Posted
12/1/2000)
- Drug Metabolism/Drug
Interaction Studies in the Drug Development Process: Studies In Vitro
(Issued
4/1997, Posted 4/8/1997)
- Exposure-Response Relationships Study Design, Data Analysis, and
Regulatory Applications [Word] or [PDF]
(Posted 5/5/2003)
- Format and Content
of the Human Pharmacokinetics and Bioavailability Section of an
Application* (Issued 2/1987, Posted 3/2/1998)
- 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)
- Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design,
Data Analysis, and Impact on Dosing and Labeling [Word]
or [PDF] (Posted 5/30/2003)
- Pharmacokinetics in
Patients with Impaired Renal Function
(Issued 5/14/1998, Posted 5/14/1998)
- Population
Pharmacokinetics (Issued 2/1999, Posted 2/10/1999)
- General
Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological
Products (Issued 11/1998, Posted 11/12/1998)
- Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on
Dosing and Labeling [HTML] or [Word] or [PDF]
(Issued 10/29/2004, Posted 10/29/2004)
Combination Products
(Drug/Device/Biologic) - Draft
- Application User Fees for Combination Products [HTML]
or [PDF]
(Issued 9/2004, Posted 10/5/004)
-
Combination Products; Timeliness of Premarket Reviews; Dispute
Resolution (Issue 5/3/2004, Posted 6/16/2004)
- A Review of FDA's
Implementation of the Drug Export Amendments of 1986
(Issued 11/1989,
Posted 3/2/1998)
- Compressed Medical
Gases (Issued 2/1989, Posted 3/10/1997)
- Computerized
Systems Used in Clinical Trials [HTML] - [Acrobat
Version] (Issued 4/1999, Posted 5/11/1999)
- General Principles of
Process Validation
- Good Laboratory
Practice Regulations Questions and Answers
(Posted 3/2/1998)
- Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities -
FDA Public Health Advisory [HTML] or [PDF] (Issued and
Posted 4/5/2001)
- 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 (Posted 3/2/1998)
- Expiration Dating
and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
(Issued
6/27/1997, Posted 6/27/1997)
- Monitoring of
Clinical Investigations
(Posted 3/2/1998)
- Nuclear Pharmacy
Guideline Criteria for Determining When to Register as a Drug
Establishment (Posted 3/2/1998)
-
Pharmacy Compounding -- Compliance Policy Guide
(Issued 5/2002, Posted 3/12/2004)
- Possible Dioxin/PCB Contamination of Drug and Biological Products [HTML] or [PDF] (Issued
8/23/1999, Posted 8/23/1999)
- Street Drug Alternatives [HTML] or [PDF] (Issued 3/2000,
Posted 3/31/2000)
- Sterile Drug
Products Produced by Aseptic Processing
(Issued 6/1987, Posted 3/2/1998)
- Computerized Systems Used in Clinical Trials [HTML]
[PDF] [Word] (Posted
9/29/2004)
- Current Good Manufacturing Practice for Medical Gases [Word]
or [PDF] (Posted 5/6/2003)
- 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)
- Investigating Out
of Specification (OOS) Test Results for Pharmaceutical Production (Issued
9/30/1998, Posted 9/30/1998)
- Manufacturing,
Processing, or Holding Active Pharmaceutical Ingredients
(Issued 4/17/1998,
Posted 4/17/1998)
- Marketed Unapproved Drugs -- Compliance Policy Guide [Word]
or [PDF] (Issued 10/15/2003, Posted 10/17/2003)
- PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML]
or [PDF] (Issued 3/29/2002, Posted 3/29/2002)
- Prescription Drug Marketing Act Regulations for Donation of Prescription
Drug Samples to Free Clinics [HTML] or [PDF]
(Issued 6/2002, Posted 6/27/2002)
- Part 11, Electronic Records; Electronic Signatures Scope and Application
[HTML] [PDF] [Word]
(Posted 9/3/2003)
- Providing Regulatory Submissions in Electronic Format ANDAs [HTML]
or [PDF] (Issued 6/2002, Posted 6/27/2002)
- Regulatory
Submissions in Electronic Format; General Considerations
(Issued 1/1999,
Posted 1/27/1999)
- Regulatory
Submissions in Electronic Format; New Drug Applications
(Issued 1/1999,
Posted 1/27/1999)
Example of an
Electronic New Drug Application Submission (Posted 2/17/1999).
Electronic Submissions Draft
- Providing Regulatory Submissions in Electronic Format - Annual Reports for
NDAs and ANDAs [Word] or [PDF]
(Posted 8/27/2003)
- Providing Regulatory Submissions in Electronic Format - Content of
Labeling [Word] or [PDF]
(Posted 2/2/2004)
- Providing Regulatory Submissions in Electronic Format - General
Considerations [Word] or [PDF]
(Issued 10/2003, Posted 10/22/2003)
-
Providing Regulatory Submissions in Electronic Format -
Human Pharmaceutical Product Applications and Related Submissions [Word]
or [PDF]. To make sure you
have the most recent versions of the specifications referenced in this
guidance please check this web page: http://www.fda.gov/cder/regulatory/ersr/ectd.htm
(Posted 8/29/2003) - Providing Regulatory Submissions in Electronic Format - Postmarketing
Expedited Safety Reports [HTML] or [PDF] (Issued 5/2001,
Posted 5/3/2001)
- Providing Regulatory Submissions in Electronic Format - Postmarketing
Periodic Adverse Drug Experience Reports [HTML] or [Word] or [PDF]
(Posted 6/23/3003)
- Providing Regulatory Submissions in Electronic Format - Prescription Drug
Advertising and Promotional Labeling [HTML] or [PDF] (Issued 1/2001,
Posted 1/30/2001)
-
180-Day Exclusivity When Multiple ANDAs Are Submitted on the
Same Day [Word] or [PDF]
(Issued 7/2003, Posted 7/31/2003)
- Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs
[HTML] or [PDF] (Posted
12/12/2000)
- ANDA's: Impurities in Drug Substances [HTML] or [PDF] (Issued
11/1999, Posted 12/2/1999)
- 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)
- Handling and Retention of BA and BE Testing Samples [Word]
or [PDF] (5/25/2004)
- Letter announcing
that the OGD will now accept the ICH long-term storage conditions as well as
the stability studies conducted in the past.
(Posted 3/2/1998)
- 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 (Posted 3/2/1998)
- 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
(Posted
3/2/1998)
- Letter on the
Provision of new information pertaining to new bioequivalence guidelines and
refuse-to-file letters
(Posted 3/2/1998)
- Letter on the
provision of new procedures and policies affecting the generic drug review
process (Posted 3/2/1998)
- 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
(Posted 3/2/1998)
- Letter on the
response to 12/20/1984 letter from the Pharmaceutical Manufacturers
Association about the Drug Price Competition and Patent Term Restoration
Act (Posted 3/2/1998)
- 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
(Posted 3/2/1998)
- Letter to
regulated industry notifying interested parties about important detailed
information regarding labeling, scale-up, packaging, minor/major amendment
criteria and bioequivalence requirements
(Posted 3/2/1998)
- Major, Minor, and Telephone Amendments to Abbreviated New Drug
Applications [PDF] (Issued 12/2001, Posted
12/20/2001)
- Organization of an
ANDA (Issued 2/1999, 3/2/1999)
- Revising ANDA Labeling Following Revision of the RLD Labeling [HTML] or [PDF] (Issued
4/26/2000, 4/26/2000)
- Skin Irritation and Sensitization Testing of Generic Transdermal Drug
Products [HTML] or
[PDF] (Issued
12/1999, Posted 2/3/2000)
- Variations in Drug
Products that May Be Included in a Single ANDA
(Issued 12/1998,
Posted 1/26/1999)
- ANDAs: Impurities
in Drug Products (Issued 12/1998, Posted 1/5/1999)
-
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 [Word] or [PDF].
(Issued 10/2004, Posted 11/3/2004)
Good Review Practices (GRPs)
- Pharmacology/Toxicology Review Format [PDF] (Posted 5/9/2001)
Good Review Practices (GRPs)
(Draft)
- Conducting a
Clinical Safety Review of a New Product Application and Preparing a Report on
the Review (11/1996)
- 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
(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
(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
(Posted 3/2/1998)
- Implementation of
the Drug Price Competition and Patent Term Restoration Act. Preliminary
Guidance (Posted 3/2/1998)
- Implementation
Plan USP injection nomenclature
(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
(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
(Posted 3/2/1998)
- Supplement to
10/11/1984 letter about policies, procedures and implementation of the Act
(Q&A format) (Posted 3/2/1998)
- Third of a series
of letters regarding the implementation of the Act (Posted 3/2/1998)
- Year 2000 Letter from Dr.
Janet Woodcock (10/19/98)
Safety
- S1A The Need for
Long-term Rodent Carcinogenicity Studies of Pharmaceuticals
- S1B Testing for
Carcinogenicity of Pharmaceuticals
(Issued 2/28/1998, Posted 3/24/1998)
- S1C Dose Selection
for Carcinogenicity Studies of Pharmaceuticals
- S1C(R) Guidance on
Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a
Limit Dose and Related Notes
(Issued 12/4/1997, Posted 12/11/1997)
- S2A Specific Aspects
of Regulatory Genotoxicity Tests for Pharmaceuticals
- S2B Genotoxicity: A
Standard Battery for Genotoxicity Testing of Pharmaceuticals
(Issued
11/21/1997, Posted 5/4/1998)
- S3A Toxicokinetics:
The Assessment of Systemic Exposure in Toxicity Studies
- S3B
Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
- S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent
Toxicity Testing) [PDF] or [Text] Posted 6/25/99
- S5A Detection of
Toxicity to Reproduction for Medicinal Products
(Issued 9/1994,
Posted 4/23/1997)
- S5B Detection of
Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male
Fertility
- S6 Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals
(Issued 11/1997,
Posted 11/18/1997)
- S7A Safety Pharmacology Studies for Human Pharmaceuticals [HTML] or [PDF] (Issued 7/2001,
Posted 7/12/2001)
Joint Safety/Efficacy (Multidisciplinary)
- M2 eCTD: Electronic Common Technical Document Specification [PDF]
(Posted 4/1/2003)
- M3 Nonclinical
Safety Studies for the Conduct of Human Clinical Trials for
Pharmaceuticals (Issued 11/1997, Posted 11/25/1997)
- M4: Common Technical Document for the Registration of Pharmaceuticals for
Human Use (Posted 10/15/2001)
- M4: Organization of the CTD [HTML] or [PDF]
- M4: The CTD -- General Questions and Answers [HTML]
or [Word]
or [PDF] (Issued 5/2004, Posted 5/5/2004)
- M4: The CTD -- Quality [HTML] or [PDF]
- M4: The CTD -- Quality Questions and Answers /Location Issues [Word]
or [PDF] or [HTML]
(Issued 6/2004, Posted 6/8/2004)
- M4: The CTD -- Efficacy [HTML] or [PDF]
- M4: The CTD -- Efficacy Questions and Answers [HTML]
or [Word]
or [PDF] (Issued 5/2004, Posted 5/5/2004)
- M4: The CTD -- Safety [HTML] or [PDF]
- M4: The CTD -- Safety Appendices [HTML] or
[WORD] or [PDF]
- M4: The CTD -- Safety Questions and Answers [WORD]
or [PDF] (Issued 2/2003, Posted 2/4/2003)
Efficacy
- E1A The Extent of
Population Exposure to Assess Clinical Safety: For Drugs Intended for
Long-term Treatment of Non-Life-Threatening Conditions
- E2A Clinical Safety
Data Management: Definitions and Standards for Expedited Reporting
- E2B International
Conference on Harmonisation; Guidance on Data Elements for Transmission of
Individual Case Safety Reports (Issued 1/15/1998, Posted 1/15/1998)
- E2C Clinical Safety
Data Management: Periodic Safety Update Reports for Marketed Drugs
(Issued
5/19/1997, Posted 3/19/1998)
- E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety
Update Reports for Marketed Drugs [Word] or [PDF]
(Posted 2/5/2004)
- E3 Structure and
Content of Clinical Study Reports
- E4 Dose-Response
Information to Support Drug Registration
- E5 Ethnic Factors in the Acceptability of Foreign
Clinical Data
- E5 Questions and Answers [HTML]
[PDF] [Word] (Issue
6/2004, Posted 6/4/2004)
- E6 Good Clinical
Practice: Consolidated Guideline
Spanish Version
(Issued 5/9/1997, Posted 3/19/1998)
- E7 Studies in Support
of Special Populations: Geriatrics
- E8 General
Considerations for Clinical Trials
(Issued 12/1997, Posted 12/17/1997)
- E9 Statistical Principles for Clinical Trials
(9/1/1998)
- E10 Choice of Control Group and Related Issues in Clinical Trials [HTML] or [PDF] (Issued 5/2001,
Posted 5/11/2001)
- E11 Clinical Investigation of Medicinal Products in the Pediatric
Population [Acrobat] (Issued
12/2000, Posted 12/14/2000)
Quality
- Q1A(R2) Stability Testing of New Drug Substances and Products [Word]
or [PDF] (Issued 11/2003, Posted 11/20/2003)
- Q1B Photostability Testing of New Drug Substances and Products [HTML] or [PDF] (Issued 11/1996,
Reposted 7/7/1998)
- Q1C Stability
Testing for New Dosage Forms
(Issued 5/9/1997, Posted 3/19/1998)
- Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances and Products [Word] or [PDF]
(Issued 1/2003, Posted 1/15/2003)
- Q1E Evaluation of Stability Data [HTML] or [PDF]
or [Word] (Issued 6/2004, Posted 6/7/2004)
- Q1F
Stability Data Package for Registration Applications in Climatic Zones III and
IV, revision 1 [HTML] or [Word] or [PDF]
(7/1/2004)
- Q2A Text on
Validation of Analytical Procedures
- Q2B Validation of
Analytical Procedures: Methodology
(Issued 5/19/1997, Posted 3/19/1997)
- Q3A Impurities in New Drug Substances [Word] or
[PDF] (Issued 2/10/2003, Posted 2/10/2003)
- Q3B(R) Impurities in New Drug Products [Word] or
[PDF] (Issued 11/2003, Posted 11/13/2003)
- Q3C Impurities:
Residual Solvents or Adobe Acrobat version
(Issued 12/24/1997, Posted 12/30/1997)
Q3C Tables and List [Word]
or [PDF] (Posted 11/12/2003) Appendix 4, Appendix 5, and Appendix 6
(Appendices were issued with the Q3C draft guidance documents)
Maintenance Procedures for Updating
(Posted 2/11/2002)
- Q5A Viral Safety Evaluation of Biotechnology
Products Derived From Cell Lines of Human or Animal Origin (Posted
9/1998)
- Q5B Quality of
Biotechnological Products: Analysis of the Expression Construct in Cells Used
for Production of r-DNA Derived Protein Products
- Q5C Quality of
Biotechnological Products: Stability Testing of Biotechnological/Biological
Products
- Q5D Quality of
Biotechnological/Biological Products: Derivation and Characterization of Cell
Substrates Used for Production of Biotechnological/Biological Products;
Availability (Issued 9/21/1998, Posted 9/21/1998)
- 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)
- Q6B Specifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products [PDF] (Issued
8/1999, Posted 12/14/2001)
- Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients [HTML]
or [PDF] (Issued
8/2001, Posted 9/24/2001]
Efficacy
- E2D Postapproval Safety Data Management: Definitions and Standards for
Expedited Reporting [PDF] or [Word]
(Posted 9/12/2003)
-
ICH E2E: Pharmacovigilance Planning (PvP) [HTML]
or [PDF]
or [Word] (Issued 11/11/2003, Posted 3/30/2004)
-
E14 Clinical Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential for Non-Antiarrhythmic Drugs [HTML]
or [PDF]
or [Word] (Issued 6/10/2004, Posted 9/10/2004)
- Principles for
Clinical Evaluation of New Antihypertensive Drugs. Optional Format:
PDF. (Issued
8/2000, Posted 8/8/2000)
Joint Safety/Efficacy
(Multidisciplinary) (Draft)
- Submitting Marketing Applications According to the ICH/CTD Format: General
Considerations (Issued 9/2001, Posted 9/5/2001) [PDF]
Quality
- Q5E Comparability of Biotechnological/Biological Products Subject to
Changes in Their Manufacturing Process [HTML] or [PDF] or [Word]
(Issued 11/13/2003, Posted 3/30/2004)
Safety
- S7B Nonclinical Evaluation of the Potential for Delayed Ventricular
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [HTML]
or [PDF]
or [Word] (Issued 6/10/2004, Posted 9/10/2004)
- Content and Format
of Investigational New Drug Applications (INDs) for Phase 1 Studies of
Drugs
- Content and Format for Geriatric Labeling [HTML] or [PDF] (Issued 10/2001,
Posted 10/4/2001)
Labeling
(Draft)
- Clinical Studies Section of Labeling for Prescription Drugs and
Biologics-- Content and Format [HTML] or [PDF] (Issued 7/2001,
Posted 7/9/2001)
- 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)
- Labeling for Combined Oral Contraceptives
[PDF] or [Word]
(Issued 3/2/2004, Posted 3/4/2004)
- 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 2/10/2004)
- Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal
Yeast Infections (Vulvovaginal Candidiasis)
(Issued 6/1998,
Posted 7/20/1998)
- Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug
Applications [HTML]
or [PDF] (Issued
10/2000, Posted 10/25/2000)
- Format and Content
of the Microbiology Section of an Application*
- Changes to an Approved NDA or ANDA [Word] or [PDF] (Issued
4/2004,
Posted 4/7/2004)
- Classifying
Resubmissions in Response to Action Letters
(Issued 5/14/1998,
Posted 5/14/1998)
- Enforcement Policy
During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic
Act or Word
Version (Issued 11/1998, Posted 11/20/1998)
- Fast Track Drug
Development Programs Designation, Development, and Application Review
Appendix 2
; Appendix
3
consisting of Mapp
6020.3 and SOPP
8405;and Appendix
4
[Appendices are scanned copies, which will be replaced by final versions
11/18] (Issued 11/17/1998, Posted 11/17/1998)
- Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] (Issued 2/2000,
Posted 3/6/2000)
- Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] (Issued 2/2000,
Posted 3/6/2000)
- 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)
- Implementation of
Section 126 of the Food and Drug Administration Modernization Act of 1997 -
Elimination of Certain Labeling Requirements
(Issued 7/1998,
Posted 7/20/98)
- Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [HTML] or [PDF] (Issued
3/2002, Posted 3/18/2002)
- National Uniformity
for Nonpresciption Drugs - Ingredient Listing for OTC Drugs
(Issued 4/1998,
Posted 5/5/1998)
- Providing Clinical
Evidence of Effectiveness for Human Drug and Biological Products
(Issued
5/14/1998, Posted 5/14/1998)
- 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)
- Repeal of Section
507 of the Federal Food, Drug and Cosmetic Act
(Revised 5/1998,
Posted 6/12/1998)
- Standards for
Prompt Review of Efficacy Supplements
(Issued 5/15/1998, Posted 5/15/1998)
- Submission of
Abbreviated Reports and Synopses in Support of Marketing Applications
(Issued 8/1998, Posted 9/15/98)
- Submitting and Reviewing Complete Responses to Clinical Holds
(Revised) [HTML] or [PDF] (Issued 10/2000,
Posted 10/25/2000
- Women and Minorities
Guidance Requirements
(Issued 7/20/1998, Posted 11/25/1998)
- Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [Word] or [PDF]
(Issued 1/2004, Posted 1/27/2004)
-
PET Drug Applications - Content and Format for NDAs and ANDAs
[HTML] or [PDF] (Issued 3/7/2000,
Posted 3/7/2000)
- Sample formats for chemistry,
manufacturing, and controls sections [PDF] or [Word97]
- Sample formats for labeling [PDF] or [Word97]
- Sample formats for Form FDA 356h [PDF] or [Word97]
- Sample formats for user fee Form FDA 3397 [PDF] or
[Word97]
- 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)
- Enforcement Policy
on Marketing OTC Combination Products (CPG 7132b.16)
(Posted 3/2/1998)
- General Guidelines
for OTC Combination Products
(Posted 3/2/1998)
- Labeling OTC Human Drug Products Using a Column Format [HTML] or [PDF] (Issued 12/2000,
Posted 12/18/2000)
- Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs [Word]
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]
- Upgrading Category
III Antiperspirants to Category I (43 FR 46728-46731)
(Posted 3/2/1998)
Over-the-Counter (OTC) Draft
- Labeling OTC Human Drug Products -Submitting Requests for Exemptions and
Deferrals [HTML] or
[PDF] (Issued
12/2000, Posted 12/18/2000)
- Labeling OTC Human Drug Products Updating Labeling in ANDAs [HTML] or [PDF] (2/21/2001)
- Time and Extent Applications [PDF] or [Word]
(Issued 2/2004, Posted 2/11/2004)
- Carcinogenicity Study Protocol Submissions [HTML] or [PDF]
(Issued 5/22/2002)
- Content and Format of INDs for Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic, Biotechnology-Derived Products [HTML] or [PDF]
- Developing Medical Imaging Drug and Biological Products
- Part 1: Conducting Safety Assessments [Word]
or [PDF] (Issued 6/17/2004, Posted 6/17/2004)
- Format and Content
of the Nonclinical Pharmacology/Toxicology Section of an Application*
(Posted
3/2/1998)
- Immunotoxicology Evaluation of Investigational New Drugs [Word]
or [PDF] (Issued 10/2002, Posted 10/31/2002)
- 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
- Photosafety Testing [Word] or [PDF]
(Posted 5/7/2003)
- 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
(Posted 3/2/1998)
- Single Dose Acute
Toxicity Testing for Pharmaceuticals
- Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in
Adult Healthy Volunteers [Word] or [PDF]
(Issued 1/2003, Posted 1/15/2003)
- Integration of Study Results to Assess Concerns about Human Reproductive
and Developmental Toxicities [PDF] (Issued
11/2001, Posted 11/9/2001)
- Nonclinical Safety Evaluation of Pediatric Drug Products [Word]
or [PDF] (Issued 1/2003, Posted 1/31/2003)
- Nonclinical Studies for Development of Pharmaceutical Excipients [Word]
or [PDF] (Issued 10/2002, Posted 10/2/2002)
- 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)
- 180-Day Generic
Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug,
and Cosmetic Act (Issued 6/1998, Posted 6/22/1998)
- Continuous Marketing Applications: Pilot 1 Reviewable Units for Fast
Track Products Under PDUFA [Word] or [PDF]
(Posted 10/1/2003)
- Continuous Marketing Applications: Pilot 2 Scientific
Feedback and Interactions During Development of Fast Track Products Under
PDUFA [Word] or [PDF]
(Posted 10/1/2003)
- Paperwork Reduction Act Burden Statement [Word]
or [PDF] (Posted 7/27/2004)
- 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)
- 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)
- Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate,
and Octisalate Labeling Enforcement Policy [Word]
or [PDF] (Posted 6/3/2003)
- Enforcement Policy
During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic
Act or Word
Version (Issued 11/1998, Posted 11/20/1998)
- Fast Track Drug Development Programs - Designation, Development, and
Application Review [HTML] or [Word] or [PDF]
(Posted 7/22/2004)
Appendix 2
; Appendix
3
consisting of Mapp
6020.3 and SOPP
8405;and Appendix
4
[Appendices are scanned copies, which will be replaced by final versions
11/18] (Issued 11/17/1998, Posted 11/17/1998)
- FDA Export Certicates [HTML]
or [PDF] (Issued
7/2004, Posted 7/13/2004)
- Financial
Disclosure by Clinical Investigators (3/27/2001)
- Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] (Issued 2/2000,
Posted 3/6/2000)
- Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] (Issued 2/2000,
Posted 3/6/2000)
- Guidance for FDA Staff: The Leveraging Handbook; An Agency
Resource for Effective Collaborations [HTML]
or [PDF] (Revised
6/2003)
- 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)
- Implementation of
Section 126 of the Food and Drug Administration Modernization Act of 1997 -
Elimination of Certain Labeling Requirements
(Issued 7/1998,
Posted 7/20/98)
- Independent Consultants for Biotechnology Clinical Trial Protocols - [HTML]
or [PDF]
(Issued 8/18/2004, Posted 8/192/2004)
- Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [HTML] or [PDF] (Issued
3/2002, Posted 3/18/2002)
- Information Request and Discipline Review Letters Under the Prescription
Drug User Fee Act [HTML]
or [PDF] (Issued
11/2001)
- 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)
- National Uniformity
for Nonpresciption Drugs - Ingredient Listing for OTC Drugs
(Issued 4/1998,
Posted 5/5/1998)
- Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies [HTML]
or [PDF] (Issued 12/2001, Posted 12/10/2001)
- KI in Radiation Emergencies-Questions and Answers [HTML]
or [PDF]
(Issued 12/20/2002, Posted 12/23/2002)
- Potassium Iodide Tablets - Shelf Life Extension [Word]
or [PDF] (Posted 3/8/2004)
- Reduction
of Civil Money Penalties for Small Entities (Issued 3/20/2001)
- 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)
- Refusal to File
(Issued 7/12/1993, Posted 11/26/99)
- Repeal of Section
507 of the Federal Food, Drug and Cosmetic Act
(Revised 5/1998,
Posted 6/12/1998)
- Special Protocol Assessment [HTML] or [PDF]
(Issued 5/2002, Posted 5/16/2002)
- Standards for
Prompt Review of Efficacy Supplements
(Issued 5/15/1998, Posted 5/15/1998)
- Submitting and Reviewing Complete Responses to Clinical Holds
(Revised) [HTML] or [PDF] (Issued 10/2000,
Posted 10/25/2000)
- Applications Covered by Section 505(b)(2) [HTML] or [PDF] or [Word] (Issued 10/1999,
Posted 12/7/1999)
- Collection of Race and Ethnicity Data in Clinical Trials [Word]
or [PDF] (Issued 1/2003, Posted 1/23/2003)
- 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)
- Disclosure of Conflicts of Interest for Special Government Employees
Participating in FDA Product Specific Advisory Committees [HTML]or
[PDF]
(2/14/2002)
- Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV
[HTML] or
[PDF]
(5/17/2004)
- Forms for Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution [HTML] or [PDF] (5/14/2001)
- Good Review Management Principles for PDUFA Products [PDF]
(Posted 7/28/2003)
- Guidance for
Clinical Trial Sponsors - On the Establishment and Operation of Clinical
Trial Data Monitoring Committees
(Posted 7/10/2003)
- Guidance for
Clinical Trial Sponsors - On the Establishment and Operation of Clinical
Trial Data Monitoring Committees
(Posted 7/10/2003)
- Independent Consultants for Biotechnology
Clinical Trial Protocols [HTML]
or [PDF] (Posted
5/7/2003)
- Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [Word] or [PDF]
(Issued 1/2004, Posted 1/27/2004)
- PET Drug
Applications - Content and Format for NDAs and ANDAs (Issued 3/7/2000,
Posted 3/7/2000)
- Pharmacogenomic Data Submissions [Word] or [PDF]
(Issued 11/2003, Posted 11/3/2003)
- Postmarketing
Safety Reporting for Human Drug and Biological Products Including Vaccines
(Issued 3/2001, Posted 3/9/2001)
- 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)
- Submitting
Debarment Certification Statements
(Issued 10/2/98, Posted 10/2/98)
- Submitting Marketing Applications According to the ICH/CTD Format: General
Considerations [PDF] (Issued 9/2001, Posted 9/5/2001)
- The
Use of Clinical Holds Following Clinical Investigator Misconduct
(Issued 4/2002, Posted 8/26/2002)
Small Entity Compliance Guides
- Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation
Small Entity Compliance Guide [PDF]
(Posted 11/7/2001)
- Classifying
Resubmissions in Response to Action Letters
(Issued 5/14/1998,
Posted 5/14/1998)
- Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act [HTML] or [PDF] (Issued 6/1999,
Posted 6/25/99)
- Information Request and Discipline Review Letters Under the Prescription
Drug User Fee Act [HTML]
or [PDF] (Issued
11/2001)
User Fees (Draft)
- Application User Fees for Combination Products [HTML]
or [PDF]
(Issued 9/2004, Posted 10/5/004)
- Submitting Separate Marketing Applications and Clinical Data for
Purposes of Assessing User Fees [PDF] (2/21/2001)
-
Attachment G -- Draft
Interim Guidance Document for Waivers of and Reductions in User Fees
(7/16/1993)
Also see Current Good Manufacturing Practice Regulations
Enforcement
of the Postmarketing Adverse Drug Experience Reporting
Regulations (Posted 8/11/1997)
[Accessibility]
Back
to Top
Regulatory Information
Date created: June 16, 2004; Updated:
November 3, 2004 |
|