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# Attorneys See Good Things in PDUFA 7 Goals
- URL: https://www.fdaweb.com/attorneys-see-good-things-in-pdufa-7-goals/
- Published: 2021-09-21T12:00:00.000Z
- Updated: 2026-09-14T17:15:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150186

Attorneys **Charles Raver** and **James Valentine** (Hyman, Phelps & McNamara) say they were excited by many of the items included in the FDA PDUFA 7 goals letter for 2023-2027 while recognizing that the real success will come from how the agency implements its goals. “From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a number of good announcements,” the two [write](https://www.thefdalawblog.com/2021/09/the-fda-pdufa-vii-goals-letter-fy-2023-2027-a-review-of-our-top-10-commitments/?ref=fdaweb.com) in their firm’s *FDA Law Blog*.

They said the most welcome commitment was the announcement that both CBER and CDER plan to hire significantly more drug review staff under PDUFA 7\. They also report that a lasting impact of the Covid-19 pandemic is that FDA intends to use some of the new inspection tools it explored during the pandemic and potentially make them more permanent fixtures of facility inspections.

The lengthy analysis lists Raver and Valentine’s top 10 programs and initiatives from the letter: 

- Split Real Time Application Review pilot;
- Rare Disease Endopoint Advancement pilot;
- CMC Development and Readiness pilot and support for accelerated development programs;
- other CMC enhancements;
- advancing real-world evidence program;
- patient-focused drug development;
- changes to pre-approval and post-approval postmarketing requirement communications;
- expansion of INTERACT meetings, new Type D meeting, and meeting follow-up questions;
- enhanced CBER capacity for cell and gene therapy products; and
- allergenic extract products added to PDUFA review.