Attorney Steven Boranian says a Louisiana federal court decision to dismiss state law claims against a gadolinium contrast manufacturer due to federal...
Federal Register notice: FDA debars Jagen Lewicki for five years from importing or offering for import any drug into the U.S.
Federal Register notice: FDA debars Matthew Dailey for 10 years from importing or offering for import any drug into the U.S.
President Trump says he has asked FDA to cut through red tape and reduce regulatory barriers, presumably to advance products associated with the coron...
CDER denies an Acer Therapeutics appeal of a 6/2019 complete response letter on an NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syn...
Janssen Pharmaceutical files an NDA for ponesimod for treating adult patients with relapsing multiple sclerosis.
FDA warns Indias Cipla Limited about CGMP violations in its production of finished drugs.
FDA warns Gojo Industries its Purell Healthcare Advanced Hand Sanitizer product line is considered an unapproved new drug that cannot be marketed unde...