US FDA Acting Commissioner’s request for an HHS OIG review related to the Alzherimer’s drug approval is fairly narrow and continues to frustrate critics who believe the drug should not be approved. Woodcock expressed confidence in the CDER team in the letter to OIG, framing the investigation request as a move to help ensure public trust in the FDA.
US Food and Drug Administration Acting Commissioner Janet Woodcock requested 9 July an independent review and assessment of the agency and Biogen, Inc.’s interactions during the lead up to the approval of Biogen’s Alzheimer’s treatment Aduhelm (aducanumab-avwa) to determine whether any interactions “were inconsistent with FDA policies and procedures.”
The move marks the second time this week the agency has taken steps to try and address the blowback it...
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.
