FDA releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi Mumbai.
FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manu...
FDA issues a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics.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...
