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Patent, Trademark, and Pharmacy Law
Patent, Trademark, and Pharmacy Law

REMS

Risk Evaluation and Mitigation Strategies

In 2007, a new law that gave FDA many new authorities and responsibilities to enhance drug safety was enacted. It's called the Food and Drug Administration Amendments Act- sometimes called "FDAAA"- and one of its provisions gave FDA the authority to require a Risk Evaluation and Mitigation Strategy-(REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. 

 

A REMs may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.

List of all approved REMS, including REMS that are no longer in place
Some are no longer in use
REMS_Materials_web.pdf
Adobe Acrobat document [171.6 KB]

List of all approved REMS, including REMS that are no longer in place

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