FDA Eases Risk Mandates For GSK, Amgen Platelet Drugs

Law360, New York (December 6, 2011, 8:19 PM EST) -- The U.S. Food and Drug Administration has eased risk mitigation requirements for GlaxoSmithKline PLC's Promacta and Amgen Inc.'s Nplate, which treat low platelet counts, the FDA said Tuesday, adding that both drugs still pose safety concerns.

The regulator has eliminated certain mandates tied to its Risk Evaluation and Mitigation Strategies, or REMS, program, which it requires to ensure the benefits of drugs outweigh the risks.

Under the eased restrictions, medical professionals and patients will no longer have to enroll in special programs to prescribe, dispense or...
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