One of the US FDA’s most prominent review managers is retiring after nearly 25 years with the agency. Ellis Unger’s departure underscores a sense of transition in the leadership and mindset of the drug center.
The US Food and Drug Administration will need a new leader for one of its largest new drug review offices following the retirement of Office of Cardiology, Hematology, Endocrinology and Nephrology Director Ellis Unger.
Unger retired at the beginning of August, wrapping up a career that spanned nearly 25 years at the agency. A...
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.
