PDUFA meeting airs industry's take on timeliness, quality of FDA communications
A required review of the FDA’s communication with industry found that communication was overall timely, collaborative and effective at moving development programs down the road. However, feedback from industry and details of an outside consultant’s report also identified some notable gaps.
The consultant-prepared communications assessment presented in an 11 August public meeting fulfilled requirements of the Prescription Drug User Fees Amendments of 2017 (PDUFA VI).
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