FDA consolidates drug application responses

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Janet Woodcock
Janet Woodcock

The FDA has announced a new procedure for responding to drug applications.

Instead of issuing “approvable” or “not approvable” letters when a drug application is denied, the FDA's Center for Drug Evaluation and Research (CDER) will issue a “complete response” at the end of the review period, according to a statement. Complete response letters will “describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval,” the statement reads.

“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 the CDER. According to the FDA, the revision will become effective on August 11, 2008.

The FDA currently responds to drug applications that don't cut the mustard with one of two letters: an “approvable” letter, which usually indicates that a drug is likely to be approved for marketing in the future, after specific achievable criteria is met; or a “not approvable” letter, meaning substantial changes or data would need to be submitted for the drug to be reconsidered for market approval.

Complete response letters are already used for biologic license applications, and the FDA said the change should not effect the time it takes to review a new or generic drug application, according to the statement.

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