Prescription drug user fee reauthorization negotiations are nearly complete, as final touches are being made to commitments for the program’s next five years.
PDUFA Renewal Negotiations Nearly Complete, With CBER Slated For Major Resource Increase
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.
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Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
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