PDUFA VII: US FDA Says Money Can’t Solve Meeting Problems
Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.
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While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.
When the closest you can get to US FDA staff is Webex, the meeting minutes and interactions with the review team project manager take on increased importance, consultants suggest during an Informa-sponsored webinar.