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# 20th Patient-Focused Drug Development Meeting
- URL: https://www.fdaweb.com/20th-patient-focused-drug-development-meeting/
- Published: 2016-10-04T12:00:00.000Z
- Updated: 2026-09-14T21:36:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136975

FDA says it recently completed its 20th patient-focused drug development meeting held as part of the PDUFA 5 agreement. CDER Office of Strategic Programs director **Theresa Mullin** writes in an *FDA Voice* blog [post](http://blogs.fda.gov/FDAvoice/index.php?ref=fdaweb.com) that under PDUFA 5 FDA committed to obtain patients’ views in at least 20 disease areas over a five-year period, ending in 9/2017\. “That means conducting a public meeting for each disease area to obtain patient perspectives on the impact of the condition on daily life and current treatment approaches,” she says.

The 20th program meeting was with patients who have received organ transplants. “With that meeting completed,” Mullin writes, “we fulfilled our commitment, one year ahead of schedule.”

The Voice of the Patient reports coming out of the meetings summarize what the agency heard through patient speaker panels, audience participation, a Webcast, and submissions to a public docket, Mullin says. The reports are intended to be useful to FDA reviewers and to the broader community.

“We believe that the long-term impact of patient-focused drug development will be better, more informed FDA decisions and oversight both during drug development and during our review of a marketing application,” she says. Although the program’s PDUFA commitment has been met, Mullin says FDA plans to hold four additional meetings by the end of FY 2017\. She also says the agency welcomes similar patient-focused meetings organized by patient groups.