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US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
FDA scientists flagged safety issues including adverse events and a patient death, leading to delayed reviews and extended timelines for drugs in the National Priority Voucher program.
- On Thursday, the U.S. Food and Drug Administration delayed review of two drugs in the Commissioner’s National Priority Voucher program after safety concerns, including a patient death, were flagged.
- Initially framed as a small pilot, the program, launched by FDA Commissioner Marty Makary, has expanded from a cap of five drugs to 18 vouchers awarded.
- FDA reviewers say the timeline omits the standard 60-day prefiling period and staffers report pressure to skip review steps despite missing data.
- That staff turnover has left the FDA drug center with 20% staff loss and its fifth director in the past year, straining review capacity.
- The program is intertwined with White House pricing efforts and remains popular there, but former FDA officials declined sign-off amid legal questions about approval authority.
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49 Articles
49 Articles
MedPage Today+3 Reposted by 3 other sources
Legal Questions Swirl Around FDA's New Expedited Drug Program
(MedPage Today) -- The effort by FDA Commissioner Marty Makary, MD, MPH, to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul...
·New York, United States
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Associated Press News+25 Reposted by 25 other sources
Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.
·New York, United States
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Coverage Details
Total News Sources49
Leaning Left12Leaning Right5Center28Last UpdatedBias Distribution62% Center
Bias Distribution
- 62% of the sources are Center
62% Center
L 27%
C 62%
11%
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