FDA to switch to complete response letters for new drug applications

July 14, 2008

Letter will inform companies that the drug review period is complete and that their application is not yet ready for approval.

Say good bye to the Food & Drug Administration's "approvable" and "not approvable" system, which the agency has been using to tell manufacturers whether their new drug applications have received approval or not. FDA said it's going to replace that system with a "complete response" letter instead. This letter will let companies know that the review period for their drug is complete and that their application is not yet ready for approval. The letter will also spell out what information is lacking and what actions companies can take to get their products ready for approval. The agency added that complete response letters are used with biologic license applications already. So shifting drugs to the same system is logical and makes for greater consistency.

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