Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.
A final rule FDA issued in January has shaken industry groups who say it creates a new legal standard for assessing a manufacturer’s “intended use” of a product that will allow any evidence to be used to bring a criminal misbranding action – thus exposing companies to potential liability for normal business activity.
Revisions to the “intended uses” regulations were included in a final rule on tobacco-derived products. “If the totality of evidence...
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.
