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Concerns Over ‘FDAAA Effect’ Absent With PDUFA V, FDA Says
The FDA should be able to handle the additional requirements of the new iteration of the Prescription Drug User Fee Act (PDUFA V) with little worry of a repeat of the infamously slowed drug reviews from five years ago, agency officials say. The FDA can comfortably handle the requirements of the PDUFA V commitment letter and implement Congress’ demands in the now-finalized legislation, CDER Director Janet Woodcock said Tuesday at the Biotechnology Industry Organization International Convention.
Washington Drug Letter |
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