U.S. Food & Drug Administration

Activity Outline
FDA Drug Topics: The Safety Evaluation and Surveillance of Generic Drugs
November 29, 2022
FDA

Activity Coordinators:

Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov), Kara Burke (Kara.Burke@fda.hhs.gov), Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)

Description

In the United States, 9 out of 10 prescriptions filled are for generic drugs. The Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research (CDER) follows a rigorous review process to ensure drug products that are approved in Abbreviated New Drug Applications (ANDAs) are of high quality, safe and considered by FDA to be therapeutically equivalent to their Reference Listed Drug (RLD). This webinar provides health care professionals with information on the evaluations performed, methods, and tools used by OGD's Office of Safety and Clinical Evaluation (OSCE) to assess the safety and effectiveness of generic drugs throughout the life-cycle of the product (e.g., pre-market and post-market setting).

References

Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (2005): https://www.fda.gov/media/72260/download
Guidance for Industry ANDAs: Impurities in Drug Products: https://www.fda.gov/media/71351/download
FDA Adverse Event Reporting System (FAERS): https://www.fda.gov/drugs/drug-approvals-and-databases/fda-adverse-event-reporting-system-faers
MedWatch: The FDA Safety Information and Adverse Event Reporting Program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Product-Specific Guidances for Generic Drug Development: https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry: https://www.fda.gov/media/102349/download

Learning Objectives

Review the methods used by FDA to monitor the safety and effectiveness of generic drugs in the pre-market and post-market setting
Identify scenarios and approaches when OGD Pharmacology/Toxicology assesses the safety of excipients in generic drug products
Describe the sources of drug impurities and how OGD Pharmacology/Toxicology assesses their safety in generic drug products and drug master files
Recognize how comparative clinical studies and other assessments are used to evaluate the bioequivalence and comparative safety of new potential generic drug products

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health Professionals (CPH), and physician assistants.

Agenda
Day 1 November 29, 2022

Time	Topic	Speaker
1:00 - 2:30 PM EST	FDA Drug Topics: The Safety Evaluation and Surveillance of Generic Drugs	Juan Crespo-Barreto, PhD Andrea Dugas, MD, PhD Xin Fu, PhD, DABT Michael Spagnola, MD

Continuing Education Accreditation

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.

This activity was planned by and for the healthcare team, and learners will receive 1.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.50 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 JA0002895-0000-22-082-L04-P, and ACPE Universal Activity Number JA0002895-0000-22-082-L04-T for 1.50 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 1.50 contact hour(s).

AAPA

This activity is designated for 1.50 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. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 1.50 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

Crespo-Barreto, Juan, PhD, Toxicologist, FDA/CDER - nothing to disclose
Dugas, Andrea, MD, PhD, Physician, FDA - nothing to disclose
Fu, Xin, PhD, DABT, Pharmacologist, FDA - nothing to disclose
Spagnola, Michael, MD, Lead Physician, US Food and Drug Administration - nothing to disclose

Planning Committee

Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
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
Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Zawalick, Karen, CE Team Leader, 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.

Registration Information
Registration is complimentary; therefore refunds are not applicable.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

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