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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
Q&A with FDA Podcast: Generics-at-a-Glance with Dr. Sarah Ibrahim
February 20, 2024 - January 17, 2027


Activity Coordinator:
Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)
Description

This enduring material provides an overview of generic drug regulation and how the FDA ensures generic drugs are safe, effective and of high-quality for the American public. It highlights the rigorous scientific and regulatory review process as well as the post-marketing activities.

References
  • Generic Drug Facts: https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
  • What Is the Approval Process for Generic Drugs?: https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs
  • Generic Drugs: Questions & Answers: https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers
  • The Generic Drug Approval Process: https://www.fda.gov/drugs/news-events-human-drugs/generic-drug-approval-process
  • FDA Ensures Equivalence of Generic Drugs: https://www.fda.gov/drugs/resources-drugs/fda-ensures-equivalence-generic-drugs
Learning Objectives
  • Describe the regulatory framework for generic drug approval in the United States.
  • Identify what information a company must submit as part of an Abbreviated New Drug Application (ANDA) including how firms must establish pharmaceutical equivalence, demonstrate bioequivalence, and the how they intend to manufacture the product to meet quality standards.
  • Explain how the FDA monitors generic drugs post-approval.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, 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 0.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-036-H99-P , and ACPE Universal Activity Number JA0002895-0000-24-036-H99-T for 0.50 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 0.50 contact hour(s).
AAPA
FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.50 AAPA Category 1 CME credits. Approval is valid until January 17, 2027. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 0.50 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 (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.

Disclosure

Faculty
  • Ibrahim, Sarah, PhD, Associate Director, FDA - nothing to disclose
  • Williams, Celia, PharmD, Pharmacist, FDA, OCOMM, DDI - nothing to disclose

Planning Committee
  • Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
  • De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - 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 100% of the activity.

Initial Release Date
February 20, 2024

Expiration Date
January 17, 2027