Drugs
Research List of Guidance Documents
Center For Drug Evaluation and Research List of 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 statutes, regulations, or both. For information on a specific guidance document, please contact the originating office (see footnote 1 in recent guidances), or contact the Division of Drug Information in the Office of Training and Communications.
Office of Training and Communications
Division of Drug Information
10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone: 301-796-3400 Fax: 301-847-8714 Internet: http://www.fda.gov/cder/guidance/index.htm e-mail:
Table of Contents (by Subject Category)
Advertising
Biopharmaceutics
Clinical Antimicrobial
CMC-Chemistry
Clinical Medical
Clinical Pharmacology
CMC - Microbiology
Combination Products (Drug/Device/Biologic)
Current Good Manufacturing Practices/Compliance
Drug Safety
Electronic Submissions
Generic Drug
Good Review Practices
ICH
IND
Industry Letters
Labeling
Modernization Act
OTC
Pharmacology/Toxicology
Procedural
Small Entity Compliance Guides
User Fee
Issued Date | |
1/12/1998 | |
8/9/1999 | |
Industry-Supported Scientific and Educational Activities (I) | 12/3/1997 |
Product Name Placement, Size, and Prominence in Advertising & Promotional Labeling | 1/24/2012 |
|
|
Issued Date | |
2/10/2004 | |
Accelerated Approval Products -- Submission of Promotional Materials (I) | 3/26/1999 |
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements(I) | 2/10/2004 |
3/12/2012 | |
Presenting Risk Information in Prescription Drug and Medical Device Promotion (I) | 5/27/2009 |
Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) (I) | 1/5/1998 |
|
|
Issued Date | |
5/23/2001 | |
3/19/2003 | |
Cholestyramine Powder In Vitro Bioequivalence (I) | 7/15/1993 |
6/2/1995 | |
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (I) | 8/25/1997 |
9/26/1997 | |
Food-Effect Bioavailability and Fed Bioequivalence Studies (I) | 1/31/2003 |
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (I) | 6/27/1989 |
2/2/2001 | |
8/31/2000 | |
|
|
Issued Date | |
Antifungal (topical) (I) | 2/24/1990 |
Antifungal (vaginal) | 2/24/1990 |
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (I) | 4/3/2003 |
|
|
| |
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product | 2/9/2012 |
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product | 2/9/2012 |
Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 | 2/9/2012 |
|
|
Issued Date | |
6/9/2004 | |
7/24/1997 | |
4/8/2004 | |
Changes to an Approved NDA or ANDA: Questions and Answers (I) | 1/22/2001 |
11/22/2004 | |
Container Closure Systems for Packaging Human Drugs and Biologics (I) | 7/7/1999 |
3/26/1996 | |
5/1/1992 | |
9/1/1989 | |
11/29/1999 | |
Environmental Assessment of Human Drug and Biologics Applications (I) | 7/27/1998 |
11/25/2009 | |
Format and Content for the CMC Section of an Annual Report (I) | 9/1/1994 |
Format and Content of the Microbiology Section of an Application* (I) | 2/1/1987 |
10/11/2011 | |
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information (I) | 5/25/2001 |
INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information (I) | 5/20/2003 |
Monoclonal Antibodies Used as Reagents in Drug Manufacturing (I) | 3/29/2001 |
7/5/2002 | |
2/25/2000 | |
12/16/2008 | |
PAC-ALTS: Postapproval Changes - Analytical Testing Laboratory Sites (I) | 4/28/1998 |
Residual Drug in Transdermal and Related Drug Delivery Systems (I) | 8/16/2011 |
5/2/2012 | |
Submitting Documentation for the Manufacturing of and Controls for Drug Products* (I) | 2/1/1987 |
Submitting Samples and Analytical Data for Methods Validation* (I) | 2/1/1987 |
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products (I) | 2/1/1987 |
11/30/1995 | |
2/18/1997 | |
2/26/1999 | |
10/6/1997 | |
6/13/1997 | |
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform (I) | 12/20/2000 |
Validation of Chromatographic Methods -- Reviewer's Guidance (I) | 11/1/1994 |
|
|
Issued Date | |
8/30/2000 | |
Assay Development for Immunogenicity Testing of Therapeutic Proteins (I) | 12/4/2009 |
CMC Postapproval Manufacturing Changes Reportable in Annual Reports (I) | 6/25/2010 |
Comparability Protocols - Chemistry, Manufacturing, and Controls Information (I) | 2/25/2003 |
9/12/2002 | |
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (I) | 7/26/1999 |
Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products | 3/1/2012 |
8/21/2002 | |
Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products (I) | 11/19/1998 |
Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework | 3/15/2011 |
12/1/2011 | |
Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications* | 11/1/1991 |
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (I) | 1/5/1999 |
Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation | 8/29/2011 |
|
|
Issued Date | |
Antiretroviral Drugs Using Plasma Human Immunodeficiency Virus Ribonucleic Acid Measurements -Clinical Considerations for Accelerated and Traditional Approval (I) | 11/1/2002 |
Antiviral Product Development -Conducting and Submitting Virology Studies to the Agency | 6/5/2006 |
Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval | 11/29/2010 |
Clinical Development and Labeling of Anti-Infective Drug Products (I) | 10/26/1992 |
9/1/1977 | |
Influenza: Developing Drugs for Treatment and/or Prophylaxis | 4/13/2011 |
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (I) | 10/31/2007 |
|
|
Issued Date | |
Acute Bacterial Exacerbation of Chronic Bronchitis in Patients with COPD; Developing Antimicrobial Drugs for Treatment (I) | 8/22/2008 |
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Acute Bacterial Otitis Media: Developing Drugs for Treatment (I) | 1/18/2008 |
Acute Bacterial Sinusitis: Developing Drugs for Treatment (I) | 10/30/2007 |
Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment | 7/22/1998 |
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment (I) | 8/27/2010 |
Acute Otitis Media; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment (I) | 10/15/2007 |
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs for Treatment (I) | 10/18/1999 |
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment | 9/14/2010 |
Community Acquired Pneumonia; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment (I) | 3/20/2009 |
Complicated Urinary Tract Infections: Developing Drugs for Treatment | 2/23/2012 |
Developing Antimicrobial Drugs -General Considerations for Clinical Trials (I) | 7/22/1998 |
Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post-Exposure) (I) | 3/18/2002 |
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products (I) | 2/17/1997 |
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (I) | 10/5/2009 |
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment | 11/29/2010 |
Lyme Disease; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Microbiological Data for Systemic Antibacterial Drug Products - Development, Analysis, and Presentation (I) | 9/17/2009 |
Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention | 8/23/2011 |
Nosocomial Pneumonia - Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Secondary Bacterial Infections of Acute Bronchitis - Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (I) | 11/23/2007 |
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Uncomplicated Gonorrhea -- Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Uncomplicated Urinary Tract Infections - Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
Vaccinia Virus -- Developing Drugs to Mitigate Complications From Smallpox Vaccination (I) | 3/9/2004 |
Vuvlovaginal Candidiasis - Developing Antimicrobial Drugs for Treatment (I) | 7/22/1998 |
|
|
Issued Date | |
Acceptance of Foreign Clinical Studies (I) | 3/13/2001 |
Antianxiety Drugs -- Clinical Evaluation (I) | 9/1/1977 |
Antidepressant Drugs -- Clinical Evaluation (I) | 9/1/1977 |
Antiepileptic Drugs (adults and children) -- Clinical Evaluation (I) | 1/1/1981 |
Available Therapy (I) | 7/23/2004 |
Calcium DTPA and Zinc DTPA Drug Products -- Submitting a New Drug Application (I) | 8/13/2004 |
Cancer Drug and Biological Products - Clinical Data in Marketing Applications (I) | 10/5/2001 |
Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment (I) | 6/2/2006 |
Clinical and Statistical Sections of an Application --Format and Content* (I) | 7/1/1988 |
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (I) | 2/17/1999 |
Clinical Endpoints for the Approval of Cancer Drugs and Biologics (I) |
|
Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products (I) | 5/16/2007 |
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (I) | 11/20/1995 |
Developing Medical Imaging Drug and Biological Products, Part 1: Conducting Safety Assessments (I) | 6/22/2004 |
Developing Medical Imaging Drug and Biological Products, Part 2: Clinical Indications (I) | 6/22/2004 |
Developing Medical Imaging Drug and Biological Products, Part 3: Design, Analysis, and Interpretation of Clinical Studies (I) | 6/22/2004 |
Development and Use of Risk Minimization Action Plans (I) |
|
Development of Vaginal Contraceptive Drugs (NDA) (I) |
|
Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (I) | 12/19/2008 |
Establishing Pregnancy Exposure Registries (I) | 9/23/2002 |
Evaluating the Risks of Drug Exposure in Human Pregnancies | 4/28/2005 |
Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children (I) | 3/6/2007 |
Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications (I) | 4/14/2006 |
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (I) | 2/2/1999 |
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (I) | 1/29/1991 |
Formatting, Assembling and Submitting New Drug and Antiobiotic Applications* (I) | 2/1/1987 |
General Anesthetics -- Clinical Evaluation (I) | 5/1/1982 |
General Considerations for the Clinical Evaluation of Drugs (I) | 12/1/1978 |
General Considerations for the Clinical Evaluation of Drugs in Infants and Children (I) | 9/1/1977 |
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (I) | 3/29/2005 |
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research | 4/4/2011 |
Hypnotic Drugs -- Clinical Evaluation (I) | 9/1/1977 |
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revised) (I) | 1/15/2004 |
Integration of Dose-Counting Mechanisms Into Metered-Dose Inhaler Drug Products (I) | 3/13/2003 |
Internal Radioactive Contamination - Development of Decorporation Agents (I) | 3/2/2006 |
Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment | 5/30/2012 |
Levothyroxine Sodium Tablets -- In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (I) | 3/8/2001 |
Local Anesthetics -- Clinical Evaluation (I) | 5/1/1982 |
MDI and DPI Drug Products -- Clinical Development and Programs (I) | 9/19/1994 |
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer (I) | 4/19/1988 |
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer (I) | 4/13/1988 |
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (I) | 12/9/2009 |
Pediatric Use Supplements --Content and Format (I) | 5/24/1996 |
Postmarketing Adverse Experience Reporting for Human Drugs and Licensed Biological Products; Clarification of What to Report (I) | 8/27/1997 |
Postmarketing Reporting of Adverse Drug Experiences (I) | 3/1/1992 |
Premarketing Risk Assessment (I) | 3/29/2005 |
Preparation of Investigational New Drug Products (Human and Animal) (I) | 11/1/1992 |
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (I) | 5/15/1998 |
Prussian Blue for Treatment of Internal Contamination With Thallium or Radioactive Cesium (I) | 2/4/2003 |
Psychoactive Drugs in Infants and Children -- Clinical Evaluation (I) | 7/1/1979 |
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (I) | 7/22/1993 |
Study of Drugs Likely to be Used in the Elderly (I) | 11/1/1989 |
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (I) | 9/13/1999 |
Summary for New Drug and Antibiotic Applications -- Format and Content* (I) | 2/1/1987 |
Systemic Lupus Erythematosus - Developing Drugs for Treatment (I) | 6/22/2010 |
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (I) | 8/2/2010 |
|
|
Issued Date | |
Acne Vulgaris: Developing Drugs for Treatment (I) | 9/19/2005 |
Allergic Rhinitis: Clinical Development Programs for Drug Products (I) | 6/21/2000 |
Anti-Anginal Drugs -- Clinical Evaluation (I) | 1/1/1989 |
Anti-Arrhythmic Drugs -- Clinical Evaluation | 7/1/1985 |
Antihypertensive Drugs -- Clinical Evaluation | 5/1/1988 |
Assessment of Abuse Potential of Drugs (I) | 1/27/2010 |
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (I) | 11/9/2007 |
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) (I) | 7/15/1999 |
Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure (I) | 12/1/1987 |
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics | 6/16/2011 |
Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees (I) | 11/20/2001 |
Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination | 12/14/2010 |
Combination Products Timeliness of Premarket Reviews (I) | 5/4/2004 |
Computerized Systems Used in Clinical Trials (I) | 10/4/2004 |
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations | 2/9/2012 |
Developing Products for Weight Management Revision 1 (I) | 2/15/2007 |
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (I) | 6/14/2000 |
Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (I) | 3/3/2008 |
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals | 9/12/2002 |
Estrogen and Estrogen/ Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms - Recommendations for Clinical Evaluation (I) | 1/31/2003 |
Exercise-Induced Bronchospasm (EIB) - Development of Drugs to Prevent EIB (I) | 2/20/2002 |
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (I) | 6/28/2005 |
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (I) | 7/26/2002 |
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (I) | 10/14/2010 |
Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs | 2/13/2012 |
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis (I) | 6/7/2007 |
OTC Treatment of Herpes Labialis with Antiviral Agents (I) | 3/8/2000 |
Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval | 5/29/2012 |
Pediatric Oncology Studies in Response to a Written Request (I) | 6/21/2000 |
Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals | 9/1/1991 |
Qualification Process for Drug Development Tools (I) | 10/25/2010 |
Recommendations for Complying with the Pediatric Rule (I) | 12/4/2000 |
Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment (I) | 11/22/2006 |
Standards for Clinical Trial Imaging Endpoints | 8/18/2011 |
Suicidality: Prospective Assessment of Occurrence in Clinical Trials (I) | 9/9/2010 |
The Use of Clinical Holds Following Clinical Investigator Misconduct (I) | 9/2/2004 |
|
|
Issued Date | |
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (I) | 4/7/1997 |
Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications (I) | 5/6/2003 |
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (I) | 2/1/1987 |
In Vivo Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (I) | 11/24/1999 |
Pharmacogenomic Data Submissions | 3/23/2005 |
Pharmacokinetics in Patients With Impaired Hepatic Function; Study Design, Data Analysis, and Impact on Dosing and Labeling (I) | 5/30/2003 |
Pharmacokinetics in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (I) | 5/15/1998 |
Population Pharmacokinetics (I) | 2/10/1999 |
|
|
Issued Date | |
Clinical Lactation Studies - Study Design, Data Analysis and Recommendations for Labeling | 2/8/2005 |
Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies | 2/18/2011 |
Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations | 2/17/2012 |
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (I) |
|
Pharmacokinetics in Pregnancy - Study Design, Data Analysis, and Impact on Dosing and Labeling (I) | 11/1/2004 |
|
|
Issued Date | |
Submission Documentation for Sterilization Process Validation Applications for Human and Veterinary Drug Products (I) | 11/1/1994 |
|
|
Issued Date | |
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (I) | 8/5/2008 |
|
|
Issued Date | |
Application User Fees for Combination Products | 4/21/2005 |
|
|
Issued Date | |
Combination Products Timeliness of Premarket Reviews; Dispute Resolution (I) | 5/4/2004 |
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (I) | 3/27/2008 |
|
|
Issued Date | |
A Review of FDA's Implementation of the Drug Export Amendments of 1986 (I) | 5/1/1990 |
Bar Code Label Requirements - Questions and Answers (Revised) (I) | 10/5/2006 |
Compressed Medical Gases (I) | 12/1/1989 |
Computerized Systems Used in Clinical Trials (I) | 5/10/1999 |
Current Good Manufacturing Practice for Phase 1 Investigational Drugs (I) | 7/15/2008 |
Current Good Manufacturing Practice for Positron Emission Tomography Drug Products (I) | 12/10/2009 |
Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products | 5/5/2011 |
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I) | 6/27/1997 |
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practices (I) | 1/12/2006 |
General Principles of Process Validation (I) | 5/1/1987 |
Good Laboratory Practice Regulations -- Questions and Answers (I) | 6/1/1981 |
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities (I) | 4/6/2001 |
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (I) | 10/12/2006 |
Marketed Unapproved Drugs;Compliance Policy Guide (I) | 9/19/2011 |
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography | 4/10/2012 |
Monitoring of Clinical Investigations (I) | 1/1/1988 |
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (I) | 5/1/1984 |
Part 11, Electronic Records, Electronic Signatures - Scope and Application | 9/5/2003 |
PET Drugs — Current Good Manufacturing Practice (CGMP) | 8/4/2011 |
Pharmaceutical Components at Risk for Melamine Contamination (I) | 8/7/2009 |
Pharmacy Compounding --Compliance Policy Guide (I) | 6/7/2002 |
Possible Dioxin/PCB Contamination of Drug and Biological Products (I) | 8/23/1999 |
Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics (I) | 3/14/2006 |
Process Analytical Technology -- A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (I) | 10/4/2004 |
Process Validation: General Principles and Practices | 1/25/2011 |
Pyrogen and Endotoxins Testing: Questions and Answers | 6/28/2012 |
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (I) | 10/2/2006 |
Sterile Drug Products Produced by Aseptic Processing (I) | 10/4/2004 |
Street Drug Alternatives (I) | 4/3/2000 |
Testing of Glycerin for Diethylene Glycol (I) | 5/2/2007 |
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP) (I) | 1/27/2010 |
|
|
Issued Date | |
Comparability Protocols -- Protein Drug Products and Biological Products -- Chemistry, Manufacturing, and Controls Information (I) | 9/5/2003 |
Current Good Manufacturing Practices for Combination Products (I) | 10/4/2004 |
Current Good Manufacturing Practices for Medical Gases (3rd Revision) (I) | 5/6/2003 |
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide | 5/31/2005 |
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (I) | 5/12/2000 |
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality | 2/10/2012 |
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, Availability (I) | 7/14/2009 |
Manufacturing, Processing or Holding of Active Pharmaceutical Ingredients (I) | 4/17/1998 |
Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment (I) | 11/7/2003 |
Repackaging of Solid Oral Dosage Form Drug Products | 2/1/1992 |
|
|
Issued Date | |
Drug Safety Information--Food and Drug Administration's Communication to the Public (I) | 3/7/2007 |
Drug-Induced Liver Injury: Premarketing Clinical Evaluation (I) | 7/30/2009 |
Medication Guides--Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies | 11/17/2011 |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic | 2/23/2012 |
Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act | 4/1/2011 |
|
|
Issued Date | |
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets | 2/16/2011 |
Classifying Significant Posmarketing Drug Safety Issues | 3/8/2012 |
Drug Safety Information -- FDA's Communication to the Public | 3/8/2012 |
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (I) | 10/1/2009 |
Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act | 4/13/2011 |
Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies (I) | 9/29/2010 |
|
|
Issued Date | |
Indexing Structured Product Labeling (I) | 6/2/2008 |
Providing Electronic Submissions in Electronic Format - ANDAs (I) | 6/27/2002 |
Providing Regulatory Submissions in Electronic Format -- Content of Labeling (I) | 4/21/2005 |
Providing Regulatory Submissions in Electronic Format -- Human Pharmaceutical Product Applications and Related Submissions (I) | 10/19/2005 |
Regulatory Submissions in Electronic Format; General Considerations (I) | 1/28/1999 |
Regulatory Submissions in Electronic Format; NDAs (I) | 1/28/1999 |
SPL Standard for Content of Labeling Technical Qs & As (I) | 10/28/2009 |
|
|
Issued Date | |
Compliance Policy on Reporting Drug Sample Distribution Information | 3/29/2012 |
Providing Regulatory Submissions in Electronic Format -- Annual Reports for New DrugApplications and Abbreviated New Drug Applications (I) | 8/28/2003 |
Providing Regulatory Submissions in Electronic Format--General Considerations (I) | 10/22/2003 |
Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports (I) | 5/4/2001 |
Providing Regulatory Submissions in Electronic Format - Postmarketing Individual Case Safety Reports (I) | 6/12/2008 |
Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports (I) | 6/24/2003 |
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling (I) | 1/31/2001 |
Providing Regulatory Submissions in Electronic Format--Receipt Date (I) | 6/5/2007 |
Providing Submissions in Electronic Format -- Standardized Study Data | 2/17/2012 |
|
|
Issued Date | |
180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day (I) | 8/1/2003 |
Abbreviated New Drug Applications: Impurities in Drug Products | 11/29/2010 |
Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAs (I) | 12/12/2000 |
ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing and Controls Information (I) | 7/15/2009 |
ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information (I) | 7/9/2007 |
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (I) | 3/30/2000 |
Handling and Retention of Bioavailability and Bioequivalence Testing Samples (I) | 5/26/2004 |
Individual Product Bioequivalence Recommendations - List of Product Bioequivalence Recommendations (I) | 6/11/2010 |
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past (I) | 8/18/1995 |
Letter describing efforts by the CDER & the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process (I) | 10/14/1994 |
Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (I) | 4/8/1994 |
Letter on the provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (I) | 7/1/1992 |
Letter on the provision of new procedures and policies affecting the generic drug review process (I) | 3/15/1989 |
Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (I) | 11/8/1991 |
Letter on the response to 12/20/84 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (I) | 3/26/1985 |
Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (I) | 1/15/1993 |
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria, and bioequivalence requirements (I) | 8/4/1993 |
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (I) | 12/21/2001 |
Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (I) | 10/26/2005 |
Revising ANDA Labeling Following Revision of the RLD Labeling (I) | 4/25/2000 |
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (I) | 5/6/2011 |
Variations in Drug Products that May Be Included in a Single ANDA (I) | 1/27/1999 |
|
|
Issued Date | |
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 (I) | 11/4/2004 |
|
|
Issued Date | |
Good Review Management Principles for Prescription Drug User Fee Act Products (I) | 3/31/2005 |
Pharmacology/Toxicology Review Format (I) | 5/10/2001 |
|
|
Issued Date | |
E1A - The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long Term Treatment of Non-Life-Threatening Conditions (I) | 3/1/1995 |
E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (I) | 3/1/1995 |
E2B - Data Elements for Transmission of Individual Case Safety Reports (I) | 1/15/1998 |
E2B(M) - Data Elements for Transmission of Individual Case Safety Reports (Revised) (I) | 4/3/2002 |
E2B(M): Data Elements for Transmission of Individual Case Safety Reports -- Questions and Answers (Revision 2) (I) | 3/9/2005 |
E2C - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (I) | 5/19/1997 |
E2C Addendum - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (I) | 2/5/2004 |
E2E - Pharmacovigilance Planning (I) | 4/1/2005 |
E2F Development Safety Update Report (I) | 8/22/2011 |
E3 - Structure and Content of Clinical Study Reports (I) | 7/17/1996 |
E4 - Dose-Response Information to Support Drug Registration (I) | 11/9/1994 |
E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data (I) | 6/10/1998 |
E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data, Questions and Answers (I) | 9/27/2006 |
E6 - Good Clinical Practice: Consolidated Guideline (I) | 5/9/1997 |
E7 - Studies in Support of Special Populations: Geriatrics (I) | 8/2/1994 |
E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers | 2/17/2012 |
E8 - General Considerations for Clinical Trials (I) | 12/24/1997 |
E9 - Statistical Principles for Clinical Trials (I) | 9/16/1998 |
E10 - Choice of Control Group and Related Issues in Clinical Trials (I) | 5/14/2001 |
E11 - Clinical Investigation of Medicinal Products in the Pediatric Population (I) | 12/15/2000 |
E14 - Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non Antiarrhythmic Drugs (I) | 10/20/2005 |
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non Antiarrhythmic Drugs. Q&As (I) | 11/18/2008 |
E15 - Pharmacogenomics Definitions and Sample Coding (I) | 4/8/2008 |
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions | 8/10/2011 |
|
|
Issued Date | |
Companion Document for M2: eCTD Specification Questions & Answers and Change Requests (I) | 8/1/2006 |
M2 - Electronic Common Technical Document Specification (eCTD) (I) | 4/2/2003 |
M3 - Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (I) | 11/25/1997 |
M3(R2) - Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (I) | 1/21/2010 |
M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers | 2/17/2012 |
M4 - Common Technical Document for the Registration of Pharmaceuticals for Human Use - Granularity Annex (I) | 10/17/2005 |
M4 - Organization of the Common Technical Document (CTD) (I) | 10/16/2001 |
M4 - The CTD -- Efficacy Questions and Answers (Revised) (I) | 12/22/2004 |
M4 - The CTD -- General Questions and Answers (Revised) (I) | 12/22/2004 |
M4 - The CTD - Quality Questions and Answers/Location Issues (I) | 6/9/2004 |
M4 - The CTD -- Safety Questions and Answers (I) | 2/4/2003 |
|
|
Issued Date | |
Final Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents | 2/22/2012 |
Q10 Pharmaceutical Quality System (I) | 4/8/2009 |
Q1A(R2) - Stability Testing of New Drug Substances and Products (I) | 11/21/2003 |
Q1B - Photostability Testing of New Drug Substances and Products (I) | 5/16/1997 |
Q1C - Stability Testing for New Dosage Forms (I) | 5/9/1997 |
Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (I) | 1/16/2003 |
Q1E - Evaluation of Stability Data (I) | 6/8/2004 |
Q2A - Text on Validation of Analytical Procedures (I) | 3/1/1995 |
Q2B - Validation of Analytical Procedures: Methodology (I) | 5/9/1997 |
Q3A(R) - Impurities in New Drug Substances (I) | 6/6/2008 |
Q3B(R) - Impurities in New Drug Products (I) | 7/31/2006 |
Q3C - Impurities: Residual Solvents (I) | 12/24/1997 |
Q3C - Tables and Lists (Revised) Recommendations for Methylpyrrolidone and Tetrahydrofuran (I) | 11/13/2003 |
Q3C Tables and List | 2/22/2012 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions -Annex 8: Sterility Test General Chapter (I) | 12/22/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2 on Test for Extractable Volume of Parenteral Preparations General Chapter (I) | 1/9/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test for Particulate Contamination: Subvisible Particles General Chapter (I) | 1/9/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (I) | 4/8/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (I) | 4/8/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions-Annex 5: Disintegration Test General Chapter (I) | 12/23/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 7(R2) Dissolution Test General Chapter | 6/23/2011 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 11: Capillary Electrophoresis General Chapter (I) | 9/3/2010 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter (I) | 9/2/2010 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts; Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter(I) | 4/8/2009 |
Q4B: Annex 1: Residue on Ignition/Sulphated Ash General Chapter (I) | 2/21/2008 |
Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (I) | 2/21/2008 |
Q5A - Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (I) | 9/24/1998 |
Q5B - Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products (I) | 2/23/1996 |
Q5C - Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products (I) | 7/10/1996 |
Q5D - Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products (I) | 9/21/1998 |
Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (I) | 6/30/2005 |
Q6A - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (I) | 12/29/2000 |
Q6B - Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (I) | 8/18/1999 |
Q7A - Good Manufacturing Practice for Active Pharmaceutical Ingredients (I) | 9/25/2001 |
Q8 (R2) - Pharmaceutical Development (I) | 11/19/2009 |
Q8, Q9, and Q10 Questions and Answers (I) | 11/1/2011 |
Q9 - Quality Risk Management (I) | 6/2/2006 |
|
|
Issued Date | |
S1A - The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals (I) | 3/1/1996 |
S1B - Testing for Carcinogenicity in Pharmaceuticals (I) | 2/23/1998 |
S1C - Dose Selection for Carcinogenicity Studies of Pharmaceuticals (I) | 3/1/1995 |
S1C(R2) - Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes (I) | 9/17/2008 |
S2A - Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (I) | 4/24/1996 |
S2B - Genotoxicity: Standard Battery Testing (I) | 11/21/1997 |
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use | 6/6/2012 |
S3A - Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (I) | 3/1/1995 |
S3B - Pharmacokinetics: Repeated Dose Tissue Distribution Studies (I) | 3/1/1995 |
S4A - Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (I) | 6/25/1999 |
S5A - Detection of Toxicity to Reproduction for Medicinal Products (I) | 9/22/1994 |
S5B - Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility (I) | 4/5/1996 |
S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | 5/17/2012 |
S7A - Safety Pharmacology Studies for Human Pharmaceuticals (I) | 7/13/2001 |
S7B - Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (I) | 10/20/2005 |
S8 - Immunotoxicity Studies for Human Pharmaceuticals (I) | 4/13/2006 |
|
|
Issued Date | |
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs (I) | 8/9/2000 |
E2B(R) - Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (I) | 10/3/2005 |
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility | 10/19/2011 |
E2C(R2) Periodic Benefit-Risk Evaluation Report | 4/10/2012 |
E2D - Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (I) | 9/15/2003 |
|
|
Issued Date | |
M5 - Data Elements and Standards for Drug Dictionaries (I) |
|
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (I) |
|
|
|
Issued Date | |
ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents - Draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene (I) | 7/20/2010 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions -Annex 13: Bulk Density and Tapped Density of Powders General Chapter (I) | 7/14/2010 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions -Annex 14: Bacterial Endotoxins Test General Chapter (I) | 7/19/2010 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions -Annex 6: Uniformity of Dosage Units General Chapter (I) | 2/17/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions-Annex 9: Tablet Friability General Chapter (I) | 8/14/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (I) | 8/14/2009 |
Q11 Development and Manufacture of Drug Substances | 6/28/2011 |
|
|
Issued Date | |
Addendum to ICH S6; Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1) (I) | 12/17/2009 |
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (I) | 2/17/2009 |
|
|
Issued Date | |
Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (I) | 10/4/2000 |
|
|
Issued Date | |
A Revision in Sample Collection Under the Compliance Program Pertaining to Pre-Approval Inspections | 7/15/1996 |
Certification Requirements for Debarred Individuals in Drug Applications | 6/1/1990 |
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 (I) | 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 (I) | 4/10/1987 |
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 (I) | 10/31/1986 |
Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance (I) | 10/11/1984 |
Implementation Plan USP injection nomenclature (I) | 10/2/1995 |
Instructions for Filing Supplements Under the Provisions of SUPAC-IR | 4/11/1996 |
Seventh of a series of letters about the Act providing guidance on the "180-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C (I) | 7/29/1988 |
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 (I) | 4/28/1988 |
Streamlining Initiatives | 12/24/1996 |
Supplement to 10/11/84 letter about policies, procedures and implementation of the Act (Q & A format) (I) | 11/16/1984 |
Third of a series of letters regarding the implementation of the Act (I) | 5/1/1985 |
Year 2000 Letter from Dr. Janet Woodcock (I) | 10/19/1998 |
|
|
Issued Date | |
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products; Content and Format (I) | 1/24/2006 |
Barbiturate, Single Entity-Class Labeling | 3/1/1981 |
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products; Content and Format (I) | 1/24/2006 |
Content and Format for Geriatric Labeling (I) | 10/5/2001 |
Hypoglycemic Oral Agents - Federal Register | 4/1/1984 |
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims | 3/15/2011 |
Labeling for Human Prescription Drug and Biological Products - Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (I) | 10/19/2009 |
Labeling Over-the-Counter Human Drug Products; Updating Labeling In Reference Listed Drugs and Abbreviated New Drug Applications (I) | 10/18/2002 |
Local Anesthetics - Class Labeling | 9/1/1982 |
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Produts and Antimicrobial Susceptibility Testing Devices (I) | 7/2/2009 |
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format (I) | 10/11/2011 |
|
|
Issued Date | |
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (I) | 3/3/2009 |
Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (I) | 4/9/2007 |
Contents of a Complete Submission for the Evaluation of Proprietary Names (I) | 11/24/2008 |
Labeling for Combined Oral Contraceptives (I) | 3/5/2004 |
Labeling for Human Prescripstion Drug and Biological Products - Implementing the New Content and Format Requirements (I) | 1/24/2006 |
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommended Prescribing Information for Health Care Providers and Patient Labeling (I) | 11/16/2005 |
Public Availability of Labeling Changes in "Changes Being Effected" Supplements (I) | 9/20/2006 |
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (I) | 10/26/2000 |
|
|
Issued Date | |
Changes to an Approved NDA or ANDA | 4/2004 |
Classifying Resubmissions in Response to Action Letters | 5/14/1998 |
Fast Track Drug Development Programs - Designation, Development, and Application Review & Appendix 2 | 7/22/2004 |
Formal Dispute Resolution: Appeals Above the Division Leve | 2/2000 |
Formal Meetings With Sponsors and Applicants for PDUFA Products | 5/19/2009 |
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees | 10/1998 |
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements | 7/1998 |
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions | 3/2002 |
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs | 4/1998 |
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products | 5/14/1998 |
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act | 9/1999 |
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act - 17 Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric "Rule," and Their Interaction | 7/27/1999 |
Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 | 2/15/2006 |
Standards for Prompt Review of Efficacy Supplements | 5/15/1998 |
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications | 8/1998 |
Submitting and Reviewing Complete Responses to Clinical Holds | 10/2000 |
|
|
Issued Date | |
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions | 1/2004 |
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act | 5/1998 |
|
|
Issued Date | |
Enforcement Policy on Marketing OTC Combination Products (CPG 71320.16) (I) | 5/1/1984 |
General Guidelines for OTC Combination Products (I) | 11/28/1978 |
Label Comprehension Studies for Nonprescription Drug Products (I) | 8/3/2010 |
Labeling OTC Human Drug Products -- Updating Labeling in ANDAs (I) | 2/22/2001 |
Labeling OTC Human Drug Products Using a Column Format (I) | 12/19/2000 |
Labeling OTC Human Drug Products; Small Entity Compliance Guide (I) | 5/13/2009 |
Labeling Over-the-Counter Human Drug Products; Questions and Answers | 1/5/2009 |
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use -Small Entity Compliance Guide (I) | 8/17/2010 |
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application (I) | 7/14/2009 |
Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (I) | 9/1/2009 |
Time and Extent Applications (I) | 9/28/2011 |
Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective | 6/21/2011 |
Upgrading Category III Antiperspirants to Category I (43 FR 46728 - 46731) (I) | 10/10/1978 |
|
|
Issued Date | |
Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals (I) | 12/19/2000 |
OTC Actual Use Studies | 7/22/1994 |
OTC Nicotine Substitutes | 3/1/1994 |
Self-Selection Studies for Nonprescription Drug Products | 9/16/2011 |
|
|
Issued Date | |
Carcinogenicity Study Protocol Submissions (I) | 5/23/2002 |
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (I) | 7/22/2005 |
Exploratory IND Studies (I) | 1/17/2006 |
Format and Content of the Nonclinical Pharmacology/ Toxicology Section of an Application (I) | 2/1/1987 |
Immunotoxicology Evaluation of Investigational New Drugs (I) | 11/1/2002 |
Nonclinical Pharmacology/Toxicology Department of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or the Development of Drugs Intended to Act as Vaginal Contraceptives (I) | 10/16/1996 |
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals | 11/25/2011 |
Nonclinical Safety Evaluation of Drug or Biologic Combinations (I) | 3/15/2006 |
Nonclinical Safety Evaluation of Pediatric Drug Products (I) | 2/15/2006 |
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients | 5/19/2005 |
Photosafety Testing (I) | 5/7/2003 |
Recommended Approaches to Integration of Genetic Toxicology Study Results (I) | 1/4/2006 |
Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (I) | 2/1/1989 |
Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns | 9/22/2011 |
Safety Testing of Drug Metabolites (I) | 2/15/2008 |
Single Dose Acute Toxicity Testing for Pharmaceuticals - Revised (I) | 8/26/1996 |
|
|
Issued Date | |
Animal Models--Essential Elements to Address Efficacy Under the Animal Rule (I) | 1/21/2009 |
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (I) | 12/16/2008 |
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (I) | 3/7/2008 |
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (I) | 5/8/2001 |
|
|
Issued Date | |
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (I) | 7/14/1998 |
Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions (I) | 12/29/2009 |
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act | 6/8/2011 |
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | 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 (I) | 11/30/1999 |
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate - Labeling Enforcement Policy (I) | 6/3/2003 |
End-of-Phase 2A Meetings (I) | 9/21/2009 |
Fast Track Drug Development Programs: Designation, Development, and Application Review (I) | 11/18/1998 |
FDA Export Certificate (I) | 7/12/2004 |
Financial Disclosure by Clinical Investigators (I) | 3/28/2001 |
Fixed Dose Combinations and Co-Packaged Drug Products for Treatment of HIV (I) | 10/18/2006 |
Formal Dispute Resolution: Appeals Above the Division Level (I) | 3/7/2000 |
Formal Meetings Between the FDA and Sponsors or Applicants (I) | 5/14/2009 |
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997- Elimination of Certain Labeling Requirements (I) | 11/2/1998 |
Implementation of Section 126 of the FDA Modernization Act of 1997 - Elimination of Certain Labeling Requirements, (I) | 7/21/1998 |
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (I) | 3/18/2002 |
Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (I) | 4/21/2009 |
Levothyroxine Sodium Products - Enforcement of August 14, 2001, Compliance Date and Submission of New Applications (I) | 7/13/2001 |
Medication Guides - Adding a Toll-Free Number for Reporting Adverse Events (I) | 6/8/2009 |
National Uniformity for Nonprescription Drugs Ingredient Labeling for OTC Drugs (I) | 4/9/1998 |
PET Drug Applications — Content and Format for NDAs and ANDAs; Fludeoxyglucose F 18 Injection; Ammonia N 13 Injection; Sodium Fluoride F 18 Injection | 8/31/2011 |
PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 | 8/31/2011 |
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products | 3/15/2011 |
Potassium Iodide (KI) in Radiation Emergencies - Questions and Answers (I) | 12/23/2002 |
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (I) | 12/10/2001 |
Potassium Iodide Tablets Shelf Life Extension for Federal Agencies and State and Local Governments (I) | 3/8/2004 |
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act - Revised (I) | 10/1/1999 |
Refusal to File (I) | 7/12/1993 |
Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act (I) | 6/15/1998 |
Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (I) | 2/16/2006 |
Special Protocol Assessment (I) | 5/17/2002 |
Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements (I) | 5/15/1998 |
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (I) | 10/26/2000 |
The Leveraging Handbook; an Agency Resource for Effective Collaborations - Guidance for FDA Staff (I) | 6/19/2003 |
"Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications" | 6/14/2012 |
Useful Written Consumer Medication Information (CMI) (I) | 7/18/2006 |
Women and Minorities Guidance Requirements | 7/20/1998 |
|
|
Issued Date | |
Applications Covered by Section 505(b)(2) (I) | 12/8/1999 |
Centralized IRB Review Proceedings in Multicenter Clinical Trials | 3/23/2005 |
Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees (I) | 11/15/2001 |
Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products (I) | 3/10/2000 |
Dear Healthcare Provider Letters: Improving Communication of Important Safety Information | 11/12/2010 |
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 CDER, Beginning January 1, 2000 (I) | 12/22/1999 |
Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees | 2/14/2002 |
Emergency Use Authroization of Medical Products: Availability (I) | 7/5/2005 |
End-of-Phase 2A Meetings (I) | 9/26/2008 |
Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application | 6/14/2011 |
FDA Oversight of PET Drug Products -- Questions and Answers | 2/24/2012 |
Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry, and FDA Staff | 5/24/2011 |
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (I) | 5/15/2001 |
Good Review Management Principles for PDUFA Products (I) | 7/28/2003 |
How to Comply with the Pediatric Research Equity Act (I) | 9/7/2005 |
Independent Consultants for Biotechnology Clinical Trial Protocols (I) | 5/7/2003 |
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (I) | 1/27/2004 |
Integrated Summary of Effectiveness (I) | 8/28/2008 |
Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage | 2/21/2012 |
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring | 8/29/2011 |
Pharmacogenomic Data Submissions (I) | 11/4/2003 |
Pharmacogenomic Data Submissions -Companion Guidance (I) | 8/29/2007 |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (I) | 1/7/2011 |
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (I) | 3/12/2001 |
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices | 12/27/2011 |
Submission of Patent Information for Certain Old Antibiotics (I) | 12/3/2008 |
Submitting Debarment Certification Statements (I) | 10/2/1998 |
Target Product Profile--A Strategic Development Process Tool (I) | 3/30/2007 |
The Use of Clinical Holds Following Clinical Investigator Misconduct (I) | 8/27/2002 |
Tropical Disease Priority Review Vouchers (I) | 10/20/2008 |
Use of Histology in Biomarker Qualification Studies | 12/29/2011 |
|
|
Issued Date | |
Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation (I) | 11/7/2001 |
|
|
Issued Date | |
Applicability of User Fees to (1) Applications Withdrawn Before Filing, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F) | 7/12/1993 |
Application, Product, and Establishment Fees: Common Issues and Their Resolution (Revised) (Attachment D) (I) | 12/16/1994 |
Classifying Resubmissions in Response to Action Letters (I) | 5/14/1998 |
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (I) | 8/25/1999 |
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (I) | 11/21/2001 |
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (I) | 1/3/2005 |
User Fee Waivers for Fixed Dose Combination Products and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (I) | 2/8/2007 |
User Fee Waivers, Reductions, and Refunds for Drug and Biological Products | 9/26/2011 |
|
|
Issued Date | |
Attachment G --Draft Interim Guidance Document for Waivers of and Reductions in User Fees (I) | 7/16/1993 |
