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Legal questions swirl around FDA's new expedited drug program, including who should sign off
WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by ...
WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...
At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner’s National Priority Voucher program, which ...
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