FDA Drug Topics: The Safety Evaluation and Surveillance of Generic Drugs
November 29, 2022
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).
- 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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry: https://www.fda.gov/media/102349/download
- 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
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health Professionals (CPH), and physician assistants.
Day 1 November 29, 2022
|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
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.
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.
- 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
- 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
- DeFronzo, 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 Tam, 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
- Darlise Henderson, MBA, Training Specialist,FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary, therefore refunds are not applicable.
Must attend 100% of the activity.
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