Clinical/Medical
|
Acceptance of Foreign Clinical Studies (PDF - 12KB)
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Final Guidance
|
03/12/01
|
Clinical / Medical
|
Acne Vulgaris: Developing Drugs for Treatment (PDF - 278KB)
|
Draft Guidance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Draft Guidance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: Clinical Development Programs for Drug Products (PDF - 68KB)
|
Draft Guidance
|
06/01/00
|
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Draft Guidance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
|
Available Therapy (PDF - 176KB)
|
Final Guidance
|
07/22/04
|
Clinical/Medical
|
Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application (PDF - 157KB)
|
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 - 205KB)
|
Final Guidance
|
06/01/06
|
Clinical / Medical
|
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (PDF - 153KB)
|
Draft Guidance
|
11/09/07
|
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Draft Guidance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
|
Clinical Evaluation of Antiepileptic Drugs (adults and children) (PDF - 1007KB)
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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 - 145KB)
|
Final Guidance
|
05/15/07
|
Clinical / Medical
|
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (PDF - 222KB)
|
Draft Guidance
|
06/16/11
|
Clinical/Medical
|
Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination (PDF - 94KB)
|
Draft Guidance
|
12/14/10
|
Clinical/Medical
|
Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
|
Final Guidance
|
09/16/05
|
Clinical/Medical; Investigational New Drug Applications
|
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
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Final Guidance
|
11/01/95
|
Clinical/Medical; Investigational New Drug Applications
|
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
|
11/01/95
|
Clinical/Medical
|
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF - 304KB)
|
Draft Guidance
|
02/09/12
|
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 - 150KB)
|
Draft Guidance
|
02/15/07
|
Clinical/Medical
|
Development and Use of Risk Minimization Action Plans (PDF - 225KB)
|
Final Guidance
|
03/24/05
|
Clinical / Medical
|
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (PDF - 20KB)
|
Draft Guidance
|
06/14/00
|
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 - 51KB)
|
Final Guidance
|
12/17/08
|
Chemistry, Manufacturing, and Controls (CMC)
|
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)
|
Draft Guidance
|
09/11/02
|
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 - 333KB)
|
|
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
|
Exercise-Induced Bronchospasm (EIB) — Development of Drugs to Prevent EIB (PDF - 210KB)
|
Draft Guidance
|
02/20/02
|
Clinical/Medical
|
Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications (PDF - 149KB)
|
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 (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 - 91KB)
|
Draft Guidance
|
01/28/05
|
Clinical/Medical
|
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
|
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 - 333KB)
|
|
03/01/06
|
|
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 - 309KB)
|
Final Guidance
|
03/01/11
|
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
|
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188KB)
|
Final Guidance
|
01/15/04
|
Clinical / Medical
|
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (PDF - 46KB)
|
Draft Guidance
|
07/26/02
|
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 - 461KB)
|
|
02/13/12
|
Clinical/Medical
|
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB)
|
Draft Guidance
|
10/13/10
|
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
|
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis (PDF - 344KB)
|
Draft Guidance
|
06/07/07
|
Clinical/Medical
|
MDI and DPI Drug Products--Clinical Development Programs for (PDF - 699KB)
|
Final Guidance
|
09/19/94
|
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 - 247KB)
|
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 - 158KB)
|
Draft Guidance
|
05/29/12
|
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 - 88KB)
|
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
|
Qualification Process for Drug Development Tools (PDF - 190KB)
|
Draft Guidance
|
10/22/10
|
Clinical / Medical
|
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 417KB)
|
Draft Guidance
|
06/03/09
|
Clinical / Medical
|
Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment (PDF - 113KB)
|
Draft Guidance
|
11/22/06
|
Clinical/Medical
|
Standards for Clinical Trial Imaging Endpoints (PDF - 266KB)
|
Draft Guidance
|
08/18/11
|
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 - 33KB)
|
|
09/01/04
|
Clinical/Medical
|
Waiver of IRB Requirements for Drug and Biological Product Studies. (PDF - 33KB)
|
Final Guidance
|
01/01/06
|
Clinical/Medical
|
Suicidal Ideation and Behavior: Prospective Assessment of Occurrance in Clinical Trials
|
Revised Draft Guidance
|
08/14/12
|