1. Pink Sheet

Map To FDA RiskMAPs

 
• By Cole Werble

Increased public scrutiny of drug safety is making risk management plans de rigeur for many new chemical entities and marketed products with definable adverse effects. FDA is using a system of special review teams to determine which plans pass muster.

It’s not new for FDA approval decisions to hinge on risk management commitments by product sponsors, but the importance of these programs is clearly increasing (See "Building a Business in Drug Safety," The RPM Report, January 2006 Also see "Building a Business in Drug Safety" - Pink Sheet, 1 January, 2006..) In the past three years, the agency has reviewed 91 risk management plans; 18 of the reviews affected new molecular entities.

Risk management strategies to educate patients and medical professionals and to assure continued monitoring in the post-approval setting are becoming...

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