PDUFA V Agreement Appears Set Between FDA And Industry
This article was originally published in The Pink Sheet Daily
Final package expected to be published in late summer following clearance by the administration.
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A repository of patient-reported outcomes instruments and dedicated PRO experts in each review division also could help boost the use of such data in drug labeling, FDA reviewers said.
One project will look at tablet size, odor and other characteristics that in the past have been a source of public complaints about generics.