Source item
Open original source ↗Quoted context
These are the quoted author’s words.
FDA shakeup: Scott Steele is now acting director of CBER. Unlike his predecessors, Steele isn’t an MD — but a molecular biologist turned science policy expert with deep White House + FDA experience. He co-authored a key 2022 paper advocating agile regulatory ecosystems to accelerate innovation. This is more than a leadership change. It signals potential for a faster, more adaptive CBER — one that can match the speed of innovation in biologics, cell & gene therapies, and regenerative medicine. If implemented right, Steele’s philosophy could enable: — Faster approvals of novel platforms — Smarter, risk-adjusted oversight — A shift from reactive to curative therapies Big win for patients and investors: shorter time to market = higher ROI. The question now is: will Steele's agile vision survive political headwinds and entrenched regulatory inertia?
Ovid_ARK ↗