| Title and Format |
Type |
Issue Date |
| Acceptance of Foreign Clinical Studies (PDF - 12 KB) |
Final |
3/12/2001 |
| Acne Vulgaris: Developing Drugs for Treatment (PDF - 284 KB) |
Draft |
9/16/2005 |
| Allergic Rhinitis: Clinical Development Programs for Drug Products (PDF - 68 KB) |
Draft |
6/2000 |
| Antianxiety Drugs--Clinical Evaluation (PDF - 2 MB) |
Final |
9/1977 |
| Antidepressant Drugs--Clinical Evaluation (PDF - 2 MB) |
Final |
9/1977 |
| Available Therapy (PDF - 176 KB) |
Final |
7/22/2004 |
| Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application (PDF - 157 KB) |
Final |
8/13/2004 |
| Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39 KB) |
Final |
10/11/2001 |
| Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment(PDF - 205 KB) |
Final |
6/1/2006 |
| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (PDF - 153 KB) |
Draft |
11/8/2007 |
| Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40 KB) |
Draft |
7/07/1999 |
| Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369 KB) |
Final |
1/1999 |
| Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice) |
Final
|
Withdrawn
8/5/2003 |
| Clinical Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal Register notice.) |
Final |
Withdrawn
7/20/2004 |
| Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children) |
Final |
Withdrawn
5/29/2008 |
| Clinical Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical Evaluation of Antiepileptic Drugs (adults and children) (PDF - 1,007 KB) |
Final |
1/1981 |
| Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical Evaluation of General Anesthetics (PDF - 890 KB) |
Final |
5/1982 |
| Clinical Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical Evaluation of Lipid-Altering Agents (PDF - 36 KB) |
Draft |
10/1990 |
| Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145 KB)
|
Final |
5/15/2007 |
| Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70 KB) |
Final |
9/16/2005 |
| Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42 KB) |
Final |
11/1995 |
| Developing Medical Imaging Drug and Biological Products
|
Final
|
6/17/2004 |
| Developing Products for Weight Management Revision 1 (PDF - 150 KB) |
Draft |
2/14/2007 |
| Development and Use of Risk Minimization Action Plans (PDF - 225 KB) |
Final |
3/24/2005 |
| Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (PDF - 20 KB) |
Draft |
5/2000 |
| Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (PDF - 265 KB) |
Draft |
2/29/2008 |
| Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (PDF - 51 KB) |
Final |
12/17/2008 |
| Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88 KB) |
Draft |
9/6/2002 |
| Establishing Pregnancy Exposure Registries (PDF - 268 KB) |
Final |
8/2002 |
| Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 333 KB) |
Final |
3/27/2006 |
| Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (PDF - 198 KB) |
Draft
|
1/2003 |
| Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3 MB) |
Final |
4/27/2005 |
| Exercise-Induced Bronchospasm (EIB) — Development of Drugs to Prevent EIB (PDF - 27 KB) |
Draft |
2/2002 |
| Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications(PDF - 149 KB) |
Final |
4/13/2006 |
| Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment (PDF - 23 KB) |
Draft |
5/2000 |
| FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58 KB) |
Final |
12/1998 |
| FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (PDF - 2 MB) |
Final |
Posted 3/2/1998 |
| FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004
|
| Format and Content of the Clinical and Statistical Sections of an Application (PDF - 1 MB) |
Final |
7/1988 |
| Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (PDF - 2 MB) |
Final |
2/1987 |
| General Considerations for the Clinical Evaluation of Drugs (PDF - 1 MB) |
Final |
|
| General Considerations for the Clinical Evaluation of Drugs in Infants and Children (PDF 2 MB) |
Final |
9/77 |
| Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (PDF -91KB) |
Draft |
6/24/ 2005 |
| Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220 KB) |
Final |
3/24/2005 |
| Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 333KB) |
Final |
3/27/2006 |
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (PDF - 2 MB) |
Draft |
8/29/2006 |
| Guidance for the Development of Vaginal Contraceptive Drugs (NDA)(PDF - 465 KB) |
Final |
3/2/1998 |
| Hypnotic Drugs--Clinical Evaluation (PDF - 2MB) |
Final |
9/77 |
| IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188 KB) |
Final |
Revised 1/15/2004 |
| Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (PDF - 27 KB) |
Draft |
7/2002 |
| Integration of Dose-Counting Mechanisms into MDI Drug Products (PDF - 126 KB) |
Final |
3/2003 |
| Internal Radioactive Contamination —Development of Decorporation Agents (PDF - 177 KB) |
Final |
3/1/2006 |
| Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (PDF - 27 KB) |
Final |
2/2001 |
| Local Anesthetics--Clinical Evaluation (PDF - 1 MB |
Final |
3/2/1998 |
| Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis (PDF - 344 KB) |
Draft |
6/6/2007 |
| MDI and DPI Drug Products--Clinical Development Programs for (PDF - 699 KB) |
Final |
9/19/1994 |
| Pediatric Use Supplements--Content and Format (PDF - 24 KB) |
Final |
5/1996 |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer (PDF - 2 MB) |
Final |
Posted 3/2/1998 |
| Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children (PDF - 247 KB) |
Final |
3/5/2007 |
| OTC Treatment of Herpes Labialis with Antiviral Agents (PDF - 15 KB) |
Draft |
3/8/2000 |
| Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 756 KB) |
Draft |
2/2/2006 |
| Pediatric Oncology Studies In Response to a Written Request (PDF - 30 KB) |
Draft |
6/2000 |
| Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95 KB) |
Final |
8/27/1997 |
| Postmarketing Reporting of Adverse Drug Experiences (PDF - 7 MB) |
Final |
3/1992 |
| Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis (PDF - 50 KB) |
Draft |
4/1994 |
| Premarketing Risk Assessment(PDF - 88 KB) |
Final |
3/24/2005 |
| Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129 KB) |
Final
|
5/14/1998 |
| Prussian Blue Drug Products — Submitting a New Drug Application (PDF - 178 KB) |
Final |
1/2003 |
| Psychoactive Drugs in Infants and Children--Clinical Evaluation (PDF - 18 MB) |
Final |
3/2/1998 |
| The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 421 KB) |
Draft |
6/2/2009 |
| Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56 KB) |
Draft |
Posted 12/1/2000 |
| Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment (PDF - 113 KB) |
Draft |
Posted 11/21/2006 |
| Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (PDF - 2 MB) |
Final |
7/22/1993 |
| Study of Drugs Likely to be used in the Elderly (PDF - 1MB) |
Final |
11/1989 |
| Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43 KB) |
Final |
8/1999 |
| Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications (PDF - 1 MB) |
Final |
2/1987 |
| Systemic Lupus Erythematosus --Developing Drugs for Treatment (PDF - 403 KB) |
Draft |
3/28/2005 |
| The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 33 KB) |
Final |
9/2004 |
| Waiver of IRB Requirements for Drug and Biological Product Studies (PDF - 33 KB) |
Final |
1/2006 |
