FDA said to misuse "approvable" letters to delay decisions

06/7/2006 | Bloomberg Businessweek

Drugmakers complain the FDA is issuing "approvable" letters to gain more time to review submitted drugs, allowing the agency to avoid the six- to 10-month time limit for it to act. Some say the increase in the number of approvable letters is indicative of an overall slowdown at the agency.

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