FDA issues a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics.
Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among patients taking Neu...
Childrens Health Defense petitions FDA to ban Infants Tylenol and place Boxed Warnings on labeling for some other Tylenol products.
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.
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.
