FDA May Nix The "Not Approvable" Letter

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

Kate Fodor
Sep 12, 2004

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).

Both "approvable" and "not approvable" products are eligible to be cleared for marketing once application deficiencies have been corrected, so the decision about which type of letter to issue is "somewhat subjective" and "can lead to confusion among sponsors and the public about potential outcomes for the application," Jenkins says. The change could help eliminate the "not-approvable" stigma,...