Clinical Guidances
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Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators
OCE/CBER/CDER, April 2024 -
Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, IRBs, and Clinical Investigators
OCE/CBER/CDER, April 2024 -
Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, March 2024 -
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry
CDER/CBER, March 2024 -
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry
CDER/CBER, February 2024 -
Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry
CDER/CBER/CDRH, February 2024 -
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry
CDER/CBER/CDRH/OC/OCE/OMHHE/OWH/OCLiP/OPT, January 2024 -
Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry
CDER/CBER, December 2023 -
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
CDER/CBER, December 2023 -
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, December 2023 -
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders
CDER/CBER/CDRH/OCE, December 2023 -
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry
CDER/CBER, November 2023 -
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment; Draft Guidance for Industry
OCE/CDER/CBER/CDRH, September 2023 -
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OCE/OCLiP, September 2023 -
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry
CDER/CBER/OCE, September 2023 -
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for IRBs and Clinical Investigators
CDER/CBER/OCE, September 2023 -
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, August 2023 -
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
OCP/CDER/CBER/CDRH, August 2023 -
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry
OCE/CDER/CBER, August 2023 -
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
CDER/CBER, July 2023 -
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry
CDER/CBER, July 2023 -
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry
CDER/CBER, June 2023 -
Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry
CDER/CBER, June 2023 -
Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders
CDER/CBER/CDRH/OCE, May 2023 -
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, February 2023 -
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry
OPT/CDER/CBER/CDRH, February 2023 -
Cross Labeling Oncology Drugs in Combination Regimens; Guidance for Industry
CDER/CBER/OCE, November 2022 -
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry
CDER/CBER, November 2022 -
Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs
OPT/CDER/CBER/CDRH, September 2022 -
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, May 2022 -
Crohn’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, April 2022 -
Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, April 2022 -
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry
CDER/CBER, April 2022 -
E8(R1) General Considerations for Clinical Sutdies; Guidance for Industry
CDER/CBER, April 2022 -
Inclusion of Older Adults in Cancer Clinical Trials
CDER/CBER/OCE, March 2022 -
Population Pharmacokinetics; Guidance for Industry
CDER/CBER, February 2022 -
Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry
CDER/CBER, December 2021 -
Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, September 2021 -
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, September 2021 -
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OC, August 2021 -
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Guidance for Industry
CDER/CBER, August 2021 -
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry
OCE/CDER/CBER, July 2021 -
Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings; Draft Guidance for Industry
OCE/CDER/CBER, June 2021 -
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment; Guidance for Industry
OCE/CDER/CBER, June 2021 -
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry
CBER/CDER, December 2020 -
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry
CDER/CBER, November 2020 -
Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry
CDER/CBER, June 2020 -
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry
CDER/CBER, February 2020 -
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, February 2020 -
Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry
OCE/CDER/CBER, January 2020 -
Adaptive Design Clinical Trials for Drugs and Biologics; Guidance for Industry
CDER/CBER, November 2019 -
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry; Guidance for Industry
CDER/CBER, September 2019 -
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry
CDER/CBER, August 2019 -
Fabry Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, August 2019 -
Bacterial Vaginosis: Developing Drugs for Treatment; Guidance for Industry
CDER/CBER, August 2019 -
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Guidance for Industry
CDER/CBER, July 2019 -
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry
CDER/CBER, June 2019 -
Treatment for Heart Failure: Endpoints for Drug Development; Draft Guidance for Industry
CDER/CBER, June 2019 -
Postapproval Pregnancy Safety Studies ; Draft Guidance for Industry
CDER/CBER, May 2019 -
Clinical Lactation Studies: Considerations for Study Design; Draft Guidance for Industry
CDER/CBER, May 2019 -
Rare Diseases: Natural History Studies for Drug Development; Draft Guidance for Industry
CDER/CBER/OOPD, March 2019 -
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Guidance for Industry
CDER/CBER, March 2019 -
Pediatric HIV Infection: Drug Development for Treatment; Guidance for Industry
CDER/CBER, March 2019 -
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Guidance for Industry
CDER/CBER/OCE, March 2019 -
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry; Draft Guidance for Industry
OCE/CDER/CBER, March 2019 -
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Guidance for Industry; Draft Guidance for Industry
OCE/CDER/CBER, March 2019 -
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies ; Draft Guidance for Industry
OCE/CDER/CBER, March 2019 -
Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Draft Guidance for Industry
OCE/CDER/CBER, March 2019 -
Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products; Guidance for Industry
CDER/CBER, March 2019 -
Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
OCE/CDER/CBER, December 2018 -
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry
CDER/CBER, November 2018 -
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Guidance for Industry
CDER/CBER, October 2018 -
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development; Draft Guidance for Industry
CDER/CBER, August 2018 -
Osteoarthritis: Structural Endpoints for the Development of Drugs; Draft Guidance for Industry
CDER/CBER/CDRH, August 2018 -
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry
CDER/CBER/CDRH, July 2018 -
Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry
CDER/CBER, April 2018 -
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance for Industry
CDER/CBER, April 2018 -
BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry
CDER/CBER, February 2018 -
Use of Electronic Informed Consent in Clinical Investigations - Questions and Answers
OHRP/CDER/OGCP/CBER/CDRH, December 2016 -
Non-Inferiority Clinical Trials to Establish Effectiveness; Guidance for Industry
CDER/CBER, November 2016 -
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
CDRH, CDER, CBER, OMPT, February 2016 -
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
CDER/CBER, February 2016 -
Product Development Under the Animal Rule; Guidance for Industry
CDER/CBER, October 2015 -
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics
CDER/CBER, April 2015 -
Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption Clinical Investigations
CDRH/CBER, August 2014 -
Informed Consent Information Sheet; Draft Guidance for IRBs, Clinical Investigators, and Sponsors
CDER/CBER/CDRH, July 2014 -
Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff
CDRH/CBER, March 2014 -
Annual Reports for Approved Premarket Approval Applications (PMA); Guidance for Industry and FDA Staff
CDRH/CBER, February 2014 -
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND; Guidance for Clinical Investigators, Sponsors, and IRBs
CDER/CBER, September 2013 -
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets; Guidance for Industry and FDA Staff
CDER/CBER, May 2013 -
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals - Questions and Answers; Guidance for Industry
CDER/CBER, February 2013 -
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling; Guidance for Industry
CDER/CBER/CDRH, January 2013 -
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions; Guidance for Industry and FDA Staff
CDER/CBER, March 2012 -
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application; Guidance for Industry and Researchers
CDER/CBER, August 2010 -
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
CDRH/CBER, February 2010 -
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Guidance for Industry
CDER/CBER, January 2010 -
Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Guidance for Industry
CDER/CBER, July 2009 -
Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection
OC/CDER/CBER/CDRH/GCPP, January 2009 -
Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process
CDRH/CBER, December 2008 -
Guidance for Industry: Computerized Systems Used in Clinical Investigations
FDA/OC, May 2007 -
Real-Time Premarket Approval Application (PMA) Supplements; Guidance for Industry and FDA Staff
CDRH/CBER, April 2006 -
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
CDER/CBER, January 2006 -
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
CDRH/CBER, May 2005 -
Submitting and Reviewing Complete Responses to Clinical Holds (Revised); Guidance for Industry
CDER/CBER, October 2000 -
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA); Guidance for Industry
CDER/CBER/CDRH, February 1999 -
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products; Guidance for Industry
CDER/CBER, November 1995