#ScienceWorks Ambassadors Celebrate Reauthorization of PDUFA

#ScienceWorks Ambassadors across the country are celebrating the reauthorization of the Prescription Drug User Fee Act (PDUFA).

Millions of people in the U.S. rely on innovative medicines to improve their quality of life. This legislation helps ensure that breakthroughs in biopharmaceutical science receive timely and thorough consideration by the U.S. Food and Drug Administration (FDA)—so new drugs and treatments can become available to patients.

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#ScienceWorks Ambassadors across the country are celebrating the reauthorization of the Prescription Drug User Fee Act (PDUFA).

Millions of people in the U.S. rely on innovative medicines to improve their quality of life. This legislation helps ensure that breakthroughs in biopharmaceutical science receive timely and thorough consideration by the U.S. Food and Drug Administration (FDA)—so new drugs and treatments can become available to patients.

PDUFA was reauthorized because Congress heard from #ScienceWorks Ambassadors how important it is to keep science working.

PDUFA is an essential tool in supporting the FDA in fulfilling its mission to protect and advance public health. For the last 30 years the PDUFA program has provided additional resources to FDA for the review of new drugs, while also providing sponsors with greater predictability and enhanced engagement with the Agency during drug development. By providing the FDA with stable and predictable funding that supplements Congressional appropriations, PDUFA helps bring new medicines to patients more quickly.

The PDUFA framework allows the US to lead the world in the introduction of new medicines. Over the last five years, about 75% of novel drugs were approved in the U.S. before any other country and the FDA’s drug review program remains the gold standard for regulatory review and approval around the world.

Reauthorization of PDUFA now allows the biopharmaceutical industry to build on the program’s success.

The new law, “PDUFA VII,” will play a critical role in continuing to advance an effective, science-based regulatory review program and will further strengthen FDA’s review fundamentals. The overarching PDUFA VII efforts are aimed at modernizing the U.S. regulatory and drug development paradigm and addressing new areas such as digital health technologies, cell and gene therapies, and manufacturing.

PDUFA VII achieves these objectives by advancing important initiatives, including:

  • Strengthening scientific dialogue and advancing innovation
  • Enhancing patient-centric drug review and support safety monitoring
  • Supporting the next wave of advanced biological therapies
  • Modernizing regulatory evidence generation and drug development tools
  • Advancing digital technologies and IT infrastructure
  • Spurring innovation in manufacturing and product quality reviews
  • Building on PDUFA VI efforts to modernize FDA financial and staff resource management

Passage of PDUFA VII represents a meaningful opportunity to make further progress on advancing innovative research and development and review approaches to prepare for the future of drug development.

SAY THANK YOU!