FDA Revises Process For Responding To Drug Applications

The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA’s Center for Drug Evaluation and Research (CDER) will no longer issue “approvable” or “not approvable” letters when a drug application is not approved.

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Filed under: Pharma Industry on July 16th, 2008