FDA experts discuss the legal frameworks governing the use of investigational drugs, biological products, and devices in FDA-regulated
research and the standards governing the review and marketing authorization of such products. This enduring material addresses how FDA incorporates the patient voice in our regulatory decisions. This enduring material will also discuss innovative methods to increase patient access and participation in clinical studies such as decentralized clinical trials (DCTs) and the importance of developing digital health technologies (DHTs) to facilitate them. In the future, we expect more clinical trials to become decentralized where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants helping to minimize travel burden, improve diversity in study populations, and facilitate research on rare diseases.

• 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).

• Describe the legal framework for approving medical products at FDA and the differences between those for drugs and biologics versus devices.
• Define what decentralized clinical trials are and why such trials may improve diversity and inclusivity in clinical trials and improve trial efficiency.
  

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

• 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
• 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, 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, MS, 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 24, 2024

Expiration Date
April 23, 2027