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FDA revises drug application response process

The US Food and Drug Administration is changing the way that it informs pharma companies that their marketing application will not be approved as submitted
The US Food and Drug Administration (FDA) is changing the way that it informs pharma companies that their marketing application will not be approved as submitted.

Under new regulations governing the drug approval process the FDA's Center for Drug Evaluation and Research (CDER) will no longer issue 'approvable' or 'not approvable' letters in relation to marketing applications. The CDER will now send a 'complete response' letter at the end of the review period informing the respective drug company of the agency's decision.

Dr Janet Woodcock, director of the FDA's CDER, said: "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."

'Complete response' letters will be issued to inform pharma companies that the review period is complete and their application is not ready for approval. The letters will detail specific deficiencies and, where possible, outline recommended actions that the firm might take to get the application ready for approval.

Such letters are already used by the agency in reference to submission of biologic licence applications. The latest move by the FDA makes the process for drug and biologics approval more consistent.

Despite the change, the FDA has said that revisions will not impact on the overall time it takes the agency to review new or generic drug applications. The changes announced by the FDA will come into effect on August 11, 2008.

9th July 2008

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