FDA officials detailing the agencys new expedited IND pilot program say a central feature will be a rolling pre-IND submission process.
A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.
FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval fo...
Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products.
A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee temporary voting memb...
CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency.
Childrens Health Defense petitions FDA to ban Infants Tylenol and place Boxed Warnings on labeling for some other Tylenol products.
An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1...
