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Clinical / Medical Acne Vulgaris: Developing Drugs for Treatment (PDF - 216KB) Draft Guidance 09/19/05
Clinical / Medical Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 423KB) Draft Guidance 02/26/10
Clinical/Medical Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry (PDF - 309KB) Draft Guidance 02/12/16
Clinical/Medical Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease (PDF - 249KB) Draft Guidance 02/07/13
Clinical/Medical Analgesic Indications: Developing Drug and Biological Products (PDF - 818KB) Draft Guidance 02/05/14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Clinical/Medical Assessment of Abuse Potential of Drugs (PDF - 275KB) Draft Guidance 01/26/10
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Clinical / Medical Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (PDF - 388KB) Draft Guidance 05/19/16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Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB) Draft Guidance 07/15/99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Clinical/Medical Rheumatoid Arthritis: Developing Drug Products for Treatment (PDF - 176KB) Draft Guidance 05/30/13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 Collection of Race and Ethnicity Data in Clinical Trials (PDF - 106KB) Final Guidance 09/16/05
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 (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 (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 IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 172KB) Final Guidance 01/15/04
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 - 976KB) Draft Guidance 03/01/10
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 - 433KB) Draft Guidance 12/14/15
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

Page Last Updated: 05/19/2016
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