FDA warns Phoenix-based Vitalab about producing purportedly sterile drugs in insanitary conditions.
FDA invites applications for a CDER established conditions pilot program.
FDA sends Motif Bio a complete response letter on its NDA for iclaprim for treating acute bacterial skin and skin structure infections, requesting add...
FDA warns a Beverly Hills, CA, doctor that his Pocket Protector used in breast augmentation procedures is an unapproved medical device that is being m...
Three stakeholder groups make recommendations on an FDA proposed rule on IRB waiver or alteration of informed consent for minimal risk clinical invest...
FDA receives a $269 million (9%) budget increase its biggest in recent years in a consensus appropriations bill signed into law by President Trump. ...
FDA allows marketing of Tandems interoperable t:Slim X2 insulin infusion pump, the first of its kind.
Federal Register notice: FDA determines the regulatory review period for Anacor Pharmaceuticals Eucrisa (crisaborole), indicated for topical treatment...