FDA Floats Labeling Update For 100s Of Drugs

By Jeff Overley (May 6, 2014, 6:14 PM EDT) -- Aiming to jump-start a largely idle safety initiative, the U.S. Food and Drug Administration on Tuesday detailed plans for a government contractor to help pharmaceutical companies update warning labels for hundreds of older products.

The move stems from a 2006 regulation known as the physician labeling rule, which required prescription drugs approved after June 30, 2001, to adopt new formatting for disclosing risks, dosage and various scientific data.

That mandate has only resulted in label updates for 15 percent of the drugs on the market, and so the FDA is offering an incentive in hopes of winning voluntary compliance with the...

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