The Safety Evaluation and Surveillance of Generic Drugs
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, November 29, 2022, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: The Safety Evaluation and Surveillance of Generic Drugs. 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 provided 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).
Instructions for Learners to complete home study activities, complete evaluation, and print certificate:
- Navigate to https://ceportal.fda.gov/
- If you have an account, please login
- If you do not have an account, click on “Create an account!”
- Once you’re logged in, please complete your profile if you haven't done so already
- Navigate to the “Web-based Courses” tab
- Select the activity you want to complete
- Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear
- Begin the activity by clicking on the link at the bottom of the page
- After viewing the presentation, click on “Complete Post-test”
- After successful completion of the Post-test, click on “Complete Evaluation”
- After completion of the evaluation, you may view/print your statement of credit and/or certificate of completion
Requirements for receiving CE credits:
Review the activity, complete the post-test and evaluation. Upon completion of all required steps, physicians, physician assistants, and nurses may view/print their statement of credit directly from the CE Portal.
Pharmacists and pharmacy technicians will need to provide their NABP e-profile ID number, as well as their DOB in MMDD format in their CE Portal Profile, in order to claim CE credit. Pharmacists and pharmacy technicians should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
Initial release date: February 3, 2023
Expiration date: December 31, 2025
Resources For You