Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated ...
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of phase one clinical trials and applications to the FDA at the end of 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 ...
Donald Prater will lead the Human Foods Program and replace Kyle Diamantas, who is taking over as department commissioner.
A Food and Drug Administration official involved in scrutinizing the safety of antidepressants, COVID-19 vaccines and other ...
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 ...
Some of Makary’s decision-making seemed motivated by personal vendettas, such as his overhaul of Covid vaccine policy, or pet ...
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