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