News

FDA database provides information on drug risks


 

The Food and Drug Administration has launched an online resource with a centralized, easily-navigable layout for approved Risk Evaluation and Mitigation Strategies (REMS), required by the FDA to help ensure that health care providers have information on risks and treatment strategies associated with certain drugs.

The database will have information about currently approved individual and shared system REMS – as well as historical and released REMS – providing health care providers and the general public with necessary information for managing a known or potential serious risk associated with a drug.

A provision of the Food and Drug Administration Amendments Act, enacted in 2007, gave the FDA the authority to require a REMS from manufacturers if the drug has potential risks associated with its use.

To access the database, go to this FDA website.

mbock@frontlinemedcom.com

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