Drugs

Clinical / Medical

Below is a sortable table of Clinical/Medical Guidances

CategoryTitleTypeDate
Clinical/Medical Abuse-Deterrent Opioids-Evaluation and Labeling (PDF - 226KB) Final Guidance 04/01/15
Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND; Frequently Asked Questions FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions (PDF - 108KB) 03/01/12
Clinical / Medical Acne Vulgaris: Developing Drugs for Treatment (PDF - 216KB) Draft Guidance 09/19/05
Clinical / Medical Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 423KB) Draft Guidance 02/26/10
Clinical/Medical Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry (PDF - 309KB) Draft Guidance 02/12/16
Clinical/Medical Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease (PDF - 249KB) Draft Guidance 02/07/13
Clinical/Medical Analgesic Indications: Developing Drug and Biological Products (PDF - 818KB) Draft Guidance 02/05/14
Clinical/Medical Antianxiety Drugs--Clinical Evaluation (PDF - 2MB) Final Guidance 09/01/77
Clinical/Medical Antidepressant Drugs--Clinical Evaluation (PDF - 2MB) Final Guidance 09/01/77
Clinical/Medical Assessment of Abuse Potential of Drugs (PDF - 285KB) Final Guidance 01/17/17
Clinical/Medical Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application (PDF - 168KB) Final Guidance 08/13/04
Clinical/Medical Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 119KB) Final Guidance 10/11/01
Clinical/Medical Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment (PDF - 106KB) Final Guidance 06/01/06
Clinical / Medical Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (PDF - 388KB) Draft Guidance 05/19/16
Clinical / Medical Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB) Draft Guidance 07/15/99
Clinical/Medical Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB) Final Guidance 01/01/99
Clinical/Medical Rheumatoid Arthritis: Developing Drug Products for Treatment (PDF - 176KB) Draft Guidance 05/30/13
Clinical/Medical Clinical Evaluation of Antiepileptic Drugs (adults and children) (PDF - 1007KB) Final Guidance 01/01/81
Clinical/Medical Clinical Evaluation of General Anesthetics (PDF - 890KB) Final Guidance 05/01/82
Clinical/Medical Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 144KB) Final Guidance 05/15/07
Clinical / Medical Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (PDF - 343KB) Final Guidance 04/21/15
Clinical/Medical Codevelopment of Two or More New Investigational Drugs for Use in Combination (PDF - 91KB) Final Guidance 06/14/13
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB) Final Guidance 11/01/95
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers (PDF - 14KB) Final Guidance 10/01/00
Clinical/Medical Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF - 140KB) Final Guidance 02/18/16
Clinical/Medical Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (PDF - 271KB) Final Guidance 06/17/04
Clinical/Medical Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (PDF - 231KB) Final Guidance 06/17/04
Clinical/Medical Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies (PDF - 307KB) Final Guidance 06/17/04
Clinical / Medical Developing Products for Weight Management Revision 1 (PDF - 91KB) Draft Guidance 02/15/07
Clinical/Medical Development and Use of Risk Minimization Action Plans March 2005 (PDF - 128KB) Final Guidance 03/24/05
Clinical / Medical Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (PDF - 265KB) Draft Guidance 03/03/08
Clinical/Medical Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (PDF - 47KB) Final Guidance 12/17/08
Clinical/Medical Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF - 997KB) Draft Guidance 12/14/12
Clinical/Medical Establishing Pregnancy Exposure Registries (PDF - 266KB) Final Guidance 08/01/02
Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF) Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF) (PDF - 774KB) file updated with new OMB expiration date 2-4-13 03/01/06
Clinical / Medical Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (PDF - 166KB) Draft Guidance 01/31/03
Clinical/Medical Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3.1MB) Final Guidance 04/27/05
Clinical/Medical Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications (PDF - 70KB) Final Guidance 04/13/06
Clinical/Medical FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58KB) Final Guidance 12/01/98
Clinical/Medical FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (PDF - 1.6MB) Final Guidance 03/02/98
Clinical/Medical Format and Content of the Clinical and Statistical Sections of an Application: section II.G., Integrated Summary of Effectiveness Data, of this guidance is superseded by the guidance for industry Integrated Summary of Effectiveness  (PDF - 1.1MB) Final Guidance 07/01/88
Clinical/Medical Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (PDF - 1.7MB) Final Guidance 02/01/87
Clinical/Medical General Considerations for the Clinical Evaluation of Drugs (PDF - 1.4MB) Final Guidance 01/01/97
Clinical/Medical General Considerations for the Clinical Evaluation of Drugs in Infants and Children (PDF - 2.2MB) Final Guidance 09/01/77
Clinical / Medical Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (PDF - 113KB) Draft Guidance 01/28/05
Clinical/Medical Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment March 2005 (PDF - 226KB) Final Guidance 03/24/05
Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF) Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF) (PDF - 774KB) file updated with new OMB expiration date 2-4-13 03/01/06
Clinical/ Medical Guideline for Postmarketing Reporting of Adverse Drug Experiences (PDF - 3.6MB) Final Guidance 03/01/92
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors on Exception from Informed Consent Requirements for Emergency Research Exception from Informed Consent Requirements for Emergency Research (PDF - 341KB) Final Guidance 04/01/13
Clinical/Medical Guidance for the Development of Vaginal Contraceptive Drugs (NDA)[ (PDF - 465KB) Final Guidance 03/02/98
Clinical/Medical Hypnotic Drugs--Clinical Evaluation (PDF - 1.7MB) Final Guidance 09/01/77
Clinical/Medical; Pharmaceutical Quality/CMC Immunogenicity Assessment for Therapeutic Protein Products (PDF - 242KB) Final Guidance 08/13/14
Clinical/Medical Integration of Dose-Counting Mechanisms into MDI Drug Products (PDF - 125KB) Final Guidance 03/01/03
Clinical/Medical Internal Radioactive Contamination —Development of Decorporation Agents (PDF - 177KB) Final Guidance 03/01/06
Clinical/Medical Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 369KB) Final Guidance 12/03/12
Clinical/Medical Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 305KB) Final Guidance 09/10/13
Clinical / Medical Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment (PDF - 317KB) Final Guidance 05/30/12
Clinical/Medical Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (PDF - 27KB) Final Guidance 02/01/01
Clinical/Medical Local Anesthetics--Clinical Evaluation (PDF - 1MB) Final Guidance 03/02/98
Clinical/Medical Lupus Nephritis Caused by Systemic Lupus Erythematosus-- Developing Medical Products for Treatment Final Guidance - Withdrawn
Clinical / Medical Non-Inferiority Clinical Trials (PDF - 474KB) Final Guidance 11/07/16
Clinical/Medical Pediatric Use Supplements--Content and Format (PDF - 24KB) Final Guidance 05/01/96
Clinical/Medical Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer (PDF - 1.5MB) Final Guidance 03/02/98
Clinical/Medical Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children (PDF - 82KB) Final Guidance 03/05/07
Clinical/Medical Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (PDF - 287KB) Final Guidance 10/06/14
Clinical/Medical Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (final) (PDF - 295KB) Final Guidance 12/08/09
Clinical / Medical Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB) Draft Guidance 06/21/00
Clinical/Medical Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95KB) Final Guidance 08/01/97
Clinical/Medical Premarketing Risk Assessment (PDF - 130KB) Final Guidance 03/24/05
Clinical/Medical Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. (PDF - 129KB) Final Guidance 05/14/98
Clinical/Medical Prussian Blue Drug Products — Submitting a New Drug Application (PDF - 159KB) Final Guidance 01/01/03
Clinical/Medical Psychoactive Drugs in Infants and Children--Clinical Evaluation (PDF - 17.9MB) Final Guidance 03/02/98
Clinical / Medical Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 6.8MB) Final Guidance 06/03/09
Clinical / Medical Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment (PDF - 93KB) Draft Guidance 11/22/06
Clinical/Medical Clinical Trial Imaging Endpoint Process Standards (PDF - 675KB) Draft Guidance 03/04/15
Clinical/Medical Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (PDF - 1.8MB) Final Guidance 07/22/93
Clinical/Medical Study of Drugs Likely to be used in the Elderly (PDF - 1.2MB) Final Guidance 11/01/89
Clinical/Medical Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (PDF - 43KB) Final Guidance 08/01/99
Clinical/Medical Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications (PDF - 1.3MB) Final Guidance 02/01/87
Clinical/Medical Systemic Lupus Erythematosus --Developing Drugs for Treatment (PDF - 168KB) Final Guidance 06/21/10
Guidance for Industry and Clinical Investigators - The Use of Clinical Holds Following Clinical Investigator Misconduct The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 37KB) 09/01/04
Clinical/Medical Waiver of IRB Requirements for Drug and Biological Product Studies. (PDF - 30KB) Final Guidance 01/01/06
Clinical/Medical Suicidal Ideation and Behavior: Prospective Assessment of Occurrance in Clinical Trials Revised Draft Guidance 08/14/12
Procedural /Clinical/Medical Qualification Process for Drug Development Tools (PDF - 499KB) Final Guidance 01/06/14
Clinical/Medical/Procedural Qualification Process for Drug Development Tools: (Attachment) Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (PDF - 80KB) Draft Guidance 01/09/14
Clinical/Medical Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment (PDF - 337KB) Draft Guidance 03/10/14
Clinical/Medical Upper Facial Lines: Developing Botulinum Toxin Drug Products (PDF - 240KB) Draft Guidance 08/05/14
Clinical/Medical Migraine: Developing Drugs for Acute Treatment (PDF - 240KB) Draft Guidance 10/21/14
Clinical/Medical Evaluating Drug Effects on the Ability to Operate a Motor Vehicle (PDF - 190KB) Draft Guidance 01/15/15
Clinical/Medical Alcoholism: Developing Drugs for Treatment (PDF - 350KB) Draft Guidance 02/11/15
Clinical / Medical Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry (PDF - 375KB) Draft Guidance 06/09/15
Clinical / Medical; Pharmacology / Toxicology Testicular Toxicity: Evaluation During Drug Development Guidance for Industry (PDF - 302KB) Draft Guidance 07/16/15
Clinical / Medical Gastroparesis: Clinical Evaluation of Drugs for Treatment (PDF - 197KB) Draft Guidance 07/22/15
Clinical /Medical Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry (PDF - 233KB) Final Guidance 10/05/16
Clinical/Medical Nonallergic Rhinitis: Developing Drug Products for Treatment (PDF - 170KB) Draft Guidance 02/12/16
Clinical/Medical Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use Guidance for Industry (PDF - 50KB) Draft Guidance 03/08/16
Clinical / Medical Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention (PDF - 452KB) Draft Guidance 06/30/16
Clinical / Medical Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry (PDF - 565KB) Draft 08/05/16
Clinical - Medical Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry (PDF - 298KB) Draft Guidance 10/25/16
Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials (PDF) Collection of Race and Ethnicity Data in Clinical Trials - Guidance for Industry and FDA Staff (PDF - 896KB) Final Guidance 10/26/16
Clinical / Medical BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry (PDF - 178KB) Draft Guidance 11/17/16
Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials (PDF) Collection of Race and Ethnicity Data in Clinical Trials - Guidance for Industry and FDA Staff (PDF - 896KB) Final Guidance 10/26/16
Clinical/Medical Multiple Endpoints in Clinical Trials Guidance for Industry (PDF - 687KB) Draft Guidance 01/12/17
Clinical/Medical Delayed Graft Function in Kidney Transplant: Developing Drugs for Prevention: Guidance for Industry (PDF - 267KB) Draft Guidance 03/22/17
Guidance for Industry - IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188KB) 01/01/04

Page Last Updated: 05/05/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English