FDA Demands Safety Plans For 25 Drugs, Biologics

Law360, New York (March 28, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has targeted 25 medications and biologics that it sees as posing risky side effects and directed their manufacturers to prepare safety plans to ensure that they are prescribed properly.

The makers of the drugs identified in the FDA's Federal Register notice on Thursday will have to submit risk evaluation and mitigation strategies by Sept. 21, as required under last year's Food and Drug Administration Amendments Act.

“These safety plans allow patients to have continued access to certain medicines for which...
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