PDUFA VI Predictions: Industry Might Pay More, Get More From User Fees
Next iteration of user fee legislation could include reducing amount of data sponsors must collect; 21st Century Cures initiative represents ‘dry run’ that could smooth agreement, Pfizer rep says.
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Case studies demonstrating what kinds of drugs do and don’t qualify for the expedited pathway designation will be presented at an April workshop co-sponsored by the Brookings Institution.
A move toward centralized institutional review board approval of study protocols could reduce clinical trial delays; House Energy and Commerce Committee also is looking at optimizing use of real-world data in the post-market setting.
While it would not grab as much attention as creating a whole new approval pathway, BIO believes tinkering with accelerated approval to give the regulations more clarity and increase its use still could generate the change it wants at FDA.