Clinical Guidances

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• Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry
  OCE/CDER/CBER,  November 2024

• Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry
  OCE/CDER/CBER,  October 2024

• Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry
  CDER/CBER/CDRH/OPT, October 2024

• Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties
  CDER/CBER/CDRH/OCE, September 2024

• Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry
  CDER/CBER/OCE, September 2024

• Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry
  CDER/CBER, August 2024

• Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry
  OCE/CDER/CBER, August 2024

• Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry
  OCE/CDER/CBER, August 2024

• Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Draft Guidance for Industry
  OCE/CBER/CDER/CDRH/OMHHE/OWH, June 2024

• Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators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• Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, IRBs, and Clinical Investigators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• Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry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• Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry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

• 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

• Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Result From Single Enzyme Defects:  Providing Evidence of Effectiveness for Replacement or Corrective Therapies; Guidance for Industry
  CDER/CBER, March 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

• Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Guidance for Industry
  OCE/CDER/CBER, January 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

• 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

• 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