The wait for a permanent head of the FDA is continuing into the second year of the Biden Administration. One message is coming through loud and clear: the agency is clearly not a top priority for the White House ... and that might just be a good thing.
Acting US Food & Drug Administration Commissioner Janet Woodcock celebrated what must have been a bittersweet first anniversary on the job on 21 January.
Woodcock has been running FDA for a full year now, the longest interim tenure at FDA since Andrew von Eschenbach...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
