In this enduring material, FDA experts discuss how to find information related to FDA-approved drugs, information on clinical trials, and how to understand informed consent documents for clinical trials.

• FDA, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Guidance for Industry (Dec 2019) (accessed at https://www.fda.gov/media/133660/download).
• FDA, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, Guidance for Industry, Investigators, and Other Stakeholders (May 2023) (accessed at https://www.fda.gov/media/167696/download).
• FDA’s Labeling Resources for Human Prescription Drugs for Industry (Jul 2023) accessed at (accessed at https://www.fda.gov/drugs/laws-acts-and-rules/fdas-labeling-resources-human-prescription-drugs).
• FDA, Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Aug. 2023), (accessed at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent).
• FDA, 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(Aug 2023) (accessed at https://www.fda.gov/media/171667/download).
• FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making, (Apr 2023) (accessed at https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical).

• Identify where to find important information and documents related to clinical trials and medical products in the United States.
  
• Define the types of information that can be obtained from medical product labels.
  
• Explain, in general terms, the legal and ethical requirements for consent forms in clinical trials.
  

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• Bell-Vlasov, Andrea, PhD, Science Policy Analyst, Food & Drug Administration - nothing to disclose
• Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
• Bugin, Kevin, PhD, RAC, Deputy Super Office Director of Operations, US FDA - nothing to disclose
• Califf, Robert M., MD, Commissioner, Food and Drug Administration - nothing to disclose
• Donoghue, Martha, MD, Associate Director, Pediatric Oncology and Rare Cancers, Oncology Center of Excellence, FDA - nothing to disclose
• Gray, Tracy, RN, MS, MBA, Patient Engagement Lead, FDA/CDRH - nothing to disclose
• Kraus, Stefanie, JD, MPH, Senior Regulatory Counsel, FDA - nothing to disclose
• Lee, Kerry Jo, MD, Associate Director for Rare Diseases, FDA - nothing to disclose
• Liang, Wei, PhD, Regulatory Operations Staff Chief, FDA - nothing to disclose
• Marston, Hilary, MD, MPH, Chief Medical Officer, Food and Drug Administration - nothing to disclose
• Mercer, Kelly, PhD, Staff Fellow, NCTR - nothing to disclose
• Morales, Jose Pablo, MD, Senior Medical Advisor, FDA Office of Good Clinical Practice - nothing to disclose
• Myers, James, JD, Associate Director for Policy, FDA, CBER - nothing to disclose
• Pattee, Suzanne, JD, Regulatory Counsel, FDA/OC/OCPP - nothing to disclose
• Pepe, Salvatore, PharmD, MS, Senior Regulatory Review Officer, FDA/CDER/OTS/IO - nothing to disclose
• Presto, Ryan, PharmD, Regulatory Officer, FDA - nothing to disclose
• Retzky, Sandra, DO, JD, MPH, Director, OC/OCPP/OOPD - nothing to disclose
• Sacks, Leonard, MD, Associate Director for Clinical Methodology, CDER/FDA - nothing to disclose
• Summers, Jeff, MD, Associate Director Translational Sciences OOD, FDA - nothing to disclose
• Tomar, Eli, JD, MPH, Associate Director, Guidance & Legislation, FDA Center for Devices and Radiological Health (CDRH) - nothing to disclose
• Viviano, Charles, MD, PhD, Supervisory Medical Officer, FDA - nothing to disclose

• Bent, Robyn, BSN, Supervisory General Health Scientist, FDA - nothing to disclose
• Retzky, Sandra, DO, JD, MPH, Director, OC/OCPP/OOPD - nothing to disclose
• Serrano, Michael, PA-C, Investigator, Office of Regulatory Affairs - nothing to disclose
• Vaillancourt, Julienne, MPH, R. Ph, Rare Disease Liaison/Policy Advisor, FDA/CBER/OD - nothing to disclose
• Welsh, Cynthia, MD, Medical Officer, FDA - nothing to disclose

• Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Initial Release Date
April 29, 2024

Expiration Date
April 28, 2027