FDA Prepares New Vaccine Framework as Industry Awaits Guidance

The FDA is preparing to release a framework in the coming weeks that will share the regulator’s thinking on its oversight of vaccines, according to Commissioner Marty Makary.

“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 how is this going to be received,” Makary said in a fireside chat Thursday at the Food and Drug Law Institute’s annual conference.

Makary said Vinay Prasad, who was named on May 6 the new director of the Center for Biologics Research and Evaluation, is planning ...