Aug 10, 2025

Hey there, exciting news in the healthcare world! Vinay Prasad is making a comeback to the FDA to oversee vaccine, gene therapy, and blood product regulation. He left the agency two weeks ago amidst tensions over a gene therapy product and political criticisms, but now he’s back in action. It’s not clear yet if he will also continue as the FDA’s chief medical and scientific officer, but his return is certainly making waves.

In other FDA-related news, there have been concerns raised by FDA employees about staffing and impromptu expert meetings. It seems like there’s a lot of movement and change happening within the FDA, which could potentially lead to some interesting developments in the near future. Additionally, rejection letters sent to drugmakers have been published by the FDA, shedding light on the decision-making processes within the agency.

As the world of medical devices continues to evolve, staying updated on all the latest changes is crucial. STAT’s Breakthrough Device Tracker provides an authoritative database of FDA’s fast-tracked medical devices, exclusive to STAT+ subscribers. And don’t miss out on the upcoming STAT Brand Studio virtual event where industry leaders will discuss how smarter terminology and data infrastructure can accelerate clinical trial cohort creation.

There’s a lot happening in the healthcare industry, and it’s an exciting time to be a part of it. Stay tuned for more updates and breakthroughs in the world of health and medicine. Remember, knowledge is power, and staying informed is key to making a positive impact in the healthcare field. Let’s continue to strive for excellence and innovation in everything we do.

Stay healthy and informed,

Summy

Stay Well!