New website serves REMS writers

Consultancy BioTrak Market Intelligence has launched, 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.

The FDA last fall issued draft guidance on REMS format and content, a blueprint for manufacturers developing the safety strategies intended to ensure drug benefits outweigh risks.

REMS are on the rise. The FDA recently required them for erythropoiesis-stimulating agents, setting three manufacturers to the task.

- here's the announcement


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