Resources for Food and Drug Administration (FDA)

FDA clarifies approval letter wording

www.nj.com

When a drugmaker looking to market a new medicine announces it has received an "approvable letter" from the Food and Drug Administration, the average English-speaking person would probably think this is good news. In FDA-speak, an "approvable letter" actually is a rejection, telling the company it fell short of its burden to prove a drug's safety and effectiveness but it can keep trying. The only thing worse: a "non approvable" letter -- or as they say in New Jersey and New York, "fuggedaboutit."

Yesterday, the FDA in its bureaucratic wisdom decided to clarify things, issuing more than 100 pages of detailed verbiage in the Federal Register that included the announcement it is doing away with both the "approvable" and "non approvable" notices.

From now on, drug companies will either get an "approved letter" when a drug application has met all necessary standards for marketing, or what the FDA will call "a complete response letter," when a drug application is either tentatively or flatly rejected.

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