STAT+: FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks
A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for vaccines.
WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is planning to unveil new guidance for vaccine makers, focused primarily on Covid-19 shots, in the coming weeks.
“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry,” Makary said at the Food and Drug Law Institute conference on Thursday.
Makary said Vinay Prasad, the new director of the center overseeing vaccines, is meeting with industry and FDA staff as he plans to “unleash a massive framework” clarifying the FDA’s regulatory expectations for vaccines. Makary didn’t offer many more details when talking to reporters after his session, but indicated the framework would take the form of agency guidance.
