FDA revises application process

August 15, 2008

The FDA announced in a prepared statement that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Key Points

Rockville, MD-The FDA announced in a prepared statement that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. The changes, effective as of Aug. 11, should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications.

Under new regulations that govern the drug approval process, the FDA's Center for Drug Evaluation and Research (CDER) no longer will issue "approvable" or "not approvable" letters when a drug application is not approved.

Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know that the review period for a drug is complete and that the application is not yet ready for approval.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, MD, director of CDER. "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."

The switch to complete response letters was proposed by the FDA in July 2004, and the agency said it already is using the format for medicines made through biotechnology.

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