Welcome to the REMS Hub - your center of activity for Risk Management and REMS (Risk Evaluation and Mitigation Strategy) information, insights and discussions.  Here, you will find everything you need to stay abreast of this rapidly evolving discipline.  Whether you are new to REMS and just getting started, or you've been through the proverbial "regulatory ringer" a few times and are looking to keep up with the cutting edge in REMS approvals, FDA meetings, daily REMS news or gaining insights from your colleagues, the REMS Hub is the place where it all happens.

REMS Daily
Up to date news and information from the rapidly changing world of pharmaceutical risk management and REMS, including news feeds and press releases
REMS Events
A calendar of upcoming conferences, webinars and meetings about REMS and pharmaceutical risk management
Wednesday FoREMS
Our series of REMS webinars that take place on the second Wednesday of every month.  Each month we will address a new topic based on trends we identify within the world of REMS and risk management.
REMS Directory
The most comprehensive database available of information about both approved and deemed REMS, including product information, safety risks, REMS elements, REMS assessment, and associated REMS documents.
REMS White Papers
The latest in learnings, methods, and practices for attaining success in developing and managing REMS programs
REMS Case Studies
Stories about and findings from real-world REMS experiences that can help inform decisions about what to do with your product
FDA Guidance
Legislative documents and FDA guidance documents regarding REMS
REMS History
A brief history of pharmaceutical risk management, including medications that have required risk management programs, FDA guidance, and REMS.
REMS Terminology
A quick reference to the terminology and acronyms commonly used in pharmaceutical risk management and REMS.
REMS FAQs
With so much going on in REMS and pharmaceutical risk management, there are a lot of questions. Get some answers.
REMS Links
More information and links to other online resources for REMS and pharmaceutical risk management

 

 
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