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# Praise for PDUFA, Suggestions for Improvement
- URL: https://www.fdaweb.com/praise-for-pdufa-suggestions-for-improvement/
- Published: 2020-08-26T12:00:00.000Z
- Updated: 2026-09-14T16:26:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147520

Several stakeholders took advantage of an FDA 7/23 virtual public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) to praise the way PDUFA has worked for the last 30 years and offer suggestions for improvements in the 2022 PDUFA 7 reauthorization agreement. Pharmaceutical Research and Manufacturers of America (PhRMA) [said](https://www.regulations.gov/document?D=FDA-2010-N-0128-0115&ref=fdaweb.com) PDUFA “has been a success for FDA, industry, and patients,” enabling significant improvements in average review and approval time for NDAs and BLAs.

It suggests that PDUFA 7 include provisions and commitments that help address lessons learned from FDA and sponsors developing Covid-19 drugs and vaccines. Other improvements sought by PhRMA cover enhancing patient-centric drug review; advancing digital health technologies; modernizing regulatory evidence generation; optimizing FDA infrastructure, staffing, and resources, and improving FDA’s regulatory information technology infrastructure.

“By focusing on the key areas outlined above,” PhRMA concludes, “PDUFA 7 can play a critical role in continuing to advance an effective, science-based regulatory review program that helps ensure that biopharmaceutical companies continue to bring innovative medicines to patients in need.”

The National Organization for Rare Disorders [says](https://www.regulations.gov/document?D=FDA-2010-N-0128-0105&ref=fdaweb.com) it hopes four areas will be incorporated into the PDUFA 7 agreement: CBER resource needs, enhancement of the rare disease cures accelerator program, strengthen patient-focused drug development efforts, and advancements in drug development based on learnings from the pandemic.

The Milken Institute FastCures program [says](https://www.regulations.gov/document?D=FDA-2010-N-0128-0114&ref=fdaweb.com) it applauds the “significant progress previous PDUFA commitments have supported, including advances in integrating patient perspectives into drug development and review and exploring the use of real-world evidence to enhance drug development.” FasterCures’ comments focus on three priority areas: increasing diversity in clinical trials and patient engagement, enhancing transparency for patients and the biomedical ecosystem, and ensuring cell and gene therapies get to patients promptly.

The American Medical Association [says](https://www.regulations.gov/document?D=FDA-2010-N-0128-0098&ref=fdaweb.com) its considerations for the next iteration of PDUFA include health equity, drug supply chain and drug shortages, and medication quality and drug safety.

The Biotechnology Innovation Organization (BIO) says the PDUFA program “has been an overwhelming success for innovation, access, and public health.” Its [letter](https://www.regulations.gov/document?D=FDA-2010-N-0128-0091&ref=fdaweb.com) says that as a result of the Covid-19 pandemic, industry and FDA are using novel approaches to digital technologies, decentralized trials, novel mechanisms to capture outcomes, facilities inspections, and supply chain security to spur innovation and inform rapid regulatory decision-making.

BIO calls for changes in PDUFA 7 to promote gene therapies and advanced biologics, enhance scientific dialog between FDA and sponsors, optimize the new molecular entity review model, and enable modern manufacturing, quality, and inspection methods and processes.