PDUFA-V: Day 1

PDUFA provides much needed resources to the FDA.

Today marks the official implementation of PDUFA-V. The prescription drug user fee program provides much needed resources to the FDA.

As PhRMA’s latest blog post points out, PDUFA-V can do the following if implemented correctly:

  • enable more timely patient access to safe and effective new medicines through enhanced scientific communications in the drug review process;
  • provide FDA with the resources necessary to advance regulatory science and help enhance drug development and review;
  • support the development of a framework to facilitate evaluations of the benefits and risks of new medicines and integrate patient perspectives in the review process; and
  • further strengthen FDA’s already robust focus on patient safety.

AstraZeneca believes that proper implementation of PDUFA-V will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.

More resources on PDUFA can be found here.