This report was first published by Endpoints News. To see the original version, click here
Biopharma industry representatives are taking issue with some of the FDA’s more political proposals in the next round of user fee agreements, particularly ones that would limit the small business waiver to only US applicants and reduce user fees for companies that run their Phase 1 trials in the US.
Among the industry concerns: Is PDUFA “the most appropriate mechanism” for incentivizing more clinical development in the US? That’s according to the latest meeting minutes from a series of February negotiations leading up to the eighth iteration of the prescription drug user fee program and posted on Thursday.
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