FDA NEWS, UPDATES AND RESOURCES

The REMS Industry Consortium aims to assist all members of the REMS community with staying informed about drug safety with valuable insights from the FDA, including updates on recalls, safety alerts, and other essential information and resources.

These provided FDA resources should prove to be beneficial to your Risk Evaluation and Mitigation Strategies and facilitate you on your REMS journey.

News & Events for Human Drugs Updates on the latest news and events that pertain to the changes and advancements in drug development.	Drug Safety & Availability Information for consumers and health professionals on new drug warnings and other safety information.	Science & Research | Drugs Learn about the process that drives CDER science and research.
Approved Risk Evaluation and Mitigation Strategies (REMS) Links to approved individual and shared system REMS programs.	Guidance, Compliance & Regulatory Information (Biologics) Looking for FDA Guidance, Compliance, and Regulatory information?  Here are some quick links to a variety of topics.	CDER Webinars View the Center for Drug Evaluation and Research upcoming and past webinars.

FDA Working Groups Active Collaborations

Member's Only: The RIC's FDA Interactions Working Group is continually monitoring FDA publications and requests for comments on draft guidances.  To access the FDA Working Groups Active Collaborations on SharePoint, please click here. (If you do not have access, please contact info@remsconsortium.org.)