Accelerated Approval Labeling Caveat Draws Industry Ire

FDA draft proposal could lead providers, patients and insurers to mistakenly believe a drug cleared under the expedited pathway does not meet the same standards as other drugs, PhRMA and BIO say.

FDA’s proposal that the indication statement for accelerated approval drugs reflect the conditions for “continued approval” has drawn objections from two biopharmaceutical industry groups.

In May 27 comments on a recent FDA draft guidance, the Pharmaceutical Research and Manufacturers of America says such a statement is not the type of scientific information that a...

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