Inpharma 1647 - 19 Jul 2008 US FDA modifies response to drug applications The US FDA has announced revisions to the manner in which it communicates when a marketing application from a drug company cannot be approved as submitted. Under new regulations, the FDA’s Center for Drug Evaluation and Research (CDER) will no longer issue ’approvable’ or ’not approvable’ letters, but will instead issue a ’complete response’ letter at the end of a review period. The ’complete response’ letter will inform the applicant of the CDER’s decision on their marketing application, and will detail deficiencies and outline recommended actions the applicant may undertake to make the application 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", commented Dr Janet Woodcock, director of the 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". FDA. FDA Revises Process for Responding to Drug Applications. Media Release : 9 Jul 2008. Available from: URL: http://www.fda.gov 809090926 1 Inpharma 19 Jul 2008 No. 1647 1173-8324/10/1647-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

US FDA modifies response to drug applications

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Inpharma 1647 - 19 Jul 2008

US FDA modifies response to drugapplications

The US FDA has announced revisions to the mannerin which it communicates when a marketing applicationfrom a drug company cannot be approved as submitted.

Under new regulations, the FDA’s Center for DrugEvaluation and Research (CDER) will no longer issue’approvable’ or ’not approvable’ letters, but will insteadissue a ’complete response’ letter at the end of a reviewperiod. The ’complete response’ letter will inform theapplicant of the CDER’s decision on their marketingapplication, and will detail deficiencies and outlinerecommended actions the applicant may undertake tomake the application ready for approval.

"These new regulations will help the FDA adopt amore consistent and neutral way of conveyinginformation to a company when we cannot approve adrug application in its present form", commented DrJanet Woodcock, director of the CDER. "Thorough andtimely review of drug applications is a priority of theFDA, and these new processes will make ourcommunications with sponsors of applications moreconsistent".FDA. FDA Revises Process for Responding to Drug Applications. Media Release :9 Jul 2008. Available from: URL: http://www.fda.gov 809090926