FDA launches new REMS website

SILVER SPRING, Md. — The FDA has introduced a new website for Risk Evaluation and Mitigation Strategies, called REMS@FDA, to provide a standardized source of information about approved REMS.

The FDA implements REMS as a risk management plan for certain prescription drugs. Under Section 505-1 of the Federal Food, Drug, and Cosmetic Act, the FDA can approve — and patients can access — certain drugs whose risks would otherwise outweigh their benefits.

The new REMS@FDA website aims to help users:

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  Conveniently access up-to-date and comprehensive REMS information.


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  Learn about, understand, and/or comply with REMS requirements.


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  More easily compare requirements across REMS, thereby minimizing the confusion associated


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  with complying with multiple REMS programs.

A webinar titled “Introducing the REMS@FDA Website” will be held on Tuesday. To register, click here.