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FDA May Nix The "Not Approvable" Letter
The Scientist 2004, 18(17):47
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Under a new proposal, the Food & Drug Administration may stop issuing "approvable" and "not approvable" letters to drug sponsors whose applications need to be revised or amended. Instead, companies would receive a "complete response" letter similar to those already used by the FDA for biologics. Using the same name for all the letters should help clear up some of the confusion that can be caused by the current system, according to John K. Jenkins, who heads the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER).
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