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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Rare Disease Day 2024: Navigating Information. Empowering Patients and Providers
April 29, 2024 - April 28, 2027

Activity Coordinators:
Ann Sullivan (,  Sandra Retzky (

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
  • FDA, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, Guidance for Industry, Investigators, and Other Stakeholders (May 2023) (accessed at
  • FDA’s Labeling Resources for Human Prescription Drugs for Industry (Jul 2023) accessed at (accessed at
  • FDA, Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Aug. 2023), (accessed at
  • 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
  • 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
Learning Objectives
  • 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.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, and physician assistants.
Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 2 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 2.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-064-H99-P, and ACPE Universal Activity Number JA0002895-0000-24-064-H99-T for 2.00 contact hour(s).
FDA Center for Drug Evaluation and Research designates this activity for 2.00 contact hour(s).
This activity is designated for 2.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria.Approval is valid until April 28, 2027. PAs should only claim credit commensurate with the extent of their participation.
Up to 2.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal ( 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 *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
  • 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

Planning Committee
  • 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

CE Consultation and Accreditation Team
  • 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
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Requirements for Certificate of Completion (Non CE)
Must attend 80% of the activity.

Initial Release Date
April 29, 2024

Expiration Date
April 28, 2027