For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...

The U.S. Food and Drug Administration (FDA) today announced an immediate halt to new clinical trials that were shipping ...

Doing so allows you to “see the impact of what you eat” (according to the start-up Lingo), to “motivate behavior change and ...

The program significantly shortens the FDA review time for a sponsor's final drug application submission from approximately 10-12 months to 1-2 months.

One of the country's biggest food manufacturers is getting on board with Health Secretary RFK Jr.'s plans to stop the industry from using synthetic dyes. FDA Commissioner Dr. Marty Makary joins "The ...

Food and Drug Administration Commissioner Marty Makary announced that the agency intends to fast-track reviews for certain ...

Kraft Heinz will be pulling artificial dyes from its U.S. products starting in 2027 and will no longer roll out new products ...

Vinay Prasad is taking on several big roles at the FDA, solidifying his position as a top adviser to Commissioner Marty ...

Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.

FDA Commissioner Dr Marty Makary tried to allay industry concerns about recent cuts and outlined his agenda for the future.