New website serves REMS writers

Consultancy BioTrak Market Intelligence has launched REMSadvisor.com, a resource for those developing risk evaluation and mitigation strategies. REMS have become an increasingly required approval component for drugs that the FDA deems to have safety risks.

The Internet site addresses program design, implementation, and assessment, which BioTrak says have been challenging for drugmakers. Content includes methods, guidance, and REMS experiences, some related via video presentations. [Full Story]

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