Search Results for: "burst biologics"

Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

Burst Biologics, Christopher Jones

The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The …

Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »

FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

FDA-draft-guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …

FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »