CDER SBIA Pre-recorded Webinar – Risk Evaluation and Mitigation Strategies: Modifications and Revisions

CDER SBIA Pre-recorded Webinar –

Risk Evaluation and Mitigation Strategies: Modifications and Revisions - Guidance for Industry

FDA has published a notice in the Federal Register (FR) announcing the availability of the “Risk Evaluation and Mitigation Strategies: Modifications and Revisions - Guidance for Industry.”

CDER SBIA is making available the accompanying pre-recorded webinar. There will not be a live presentation. The objectives of the webinar are:

- Understand ‘changes to an approved REMS’ before and after FDASIA

- Understand the different categories of REMS changes in the draft guidance

- Understand Application Holder Submission Procedures for the different types of REMS changes

- Understand FDA’s proposed process for reviewing and acting on different types of REMS changes 

-View Webinar Here: Risk Evaluation and Mitigation Strategies: Modifications and Revisions

-Listen to Webinar (Audio Only) Here: Risk Evaluation and Mitigation Strategies: Modifications and Revisions (MP3 - 44.2MB)

-Download Presentation Slides: Risk Evaluation and Mitigation Strategies: Modifications and Revisions (PDF - 2.22MB)

For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

CDER SBIA webinar series