The sponsor’s proposal for a post-approval cohort safety study in 30,000 patients failed to alleviate the concerns of a majority of the vaccines advisory committee, which voted 8 to 5 with one abstention that available data do not support the safety of the hepatitis B vaccine.
Members of the Vaccines and Related Biological Products Advisory Committee did not find the promise for a 30,000-patient post-market safety study sufficient to assuage their concerns about the risks of approving Dynavax Technologies Corp.’s hepatitis B vaccine Heplisav (rHBsAg-1018 ISS) for the general adult population.
The panel voted 8 to 5 with one abstention that available data do not support the safety of the vaccine...
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.
