Commissioner Hamburg says conversations are underway with industry to allow the agency to release its reasons for not approving a product, in part so others will not waste funds repeating known failures. FDA is also working to remove user fee revenue from sequestration.
FDA Commissioner Margaret Hamburg is working with industry to find a way for it to make “complete response” letters public.
Aside from shining a light on application problems and failures, which have been tightly held sponsor secrets, the move also...