Androfen should discontinue claims its testosterone-boosting supplement can “reduce body fat by over 200%” because consumers can interpret it in a way that is not supported, ERSP says. The firm can continue to claim the fenugreek product enhances libido and promotes body fat loss.
Androfen LLC cites differences in test groups’ results to claim its testosterone-boosting supplement could “reduce body fat by over 200%,” but the Electronic Retailing Self-Regulation Program says the firm’s calculations likely will not add up for consumers.
Androfen should discontinue the claim for its eponymous-branded product because consumers can interpret it in a way not supported by...
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.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
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.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
