Federal Register notice: FDA announces a list of 1,003 Class 2 devices that the agency is proposing to exempt or partially exempt from premarket notif...
FDA says it is lifting an import alert placed on Sun Pharmas Mohali drug manufacturing facility in 2013.
FDA warns Indias Badrivishal Chemicals & Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Chinas Lumis Global Pharmaceuticals about CGMP deviations and misbranding violations in its manufacturing of active pharmaceutical ingredien...
Hogan Lovells attorneys says 2016 was a year of expansion for the False Claims Act, netting the government nearly $5 billion in recoveries, and there ...
FDA says the Medtronic recall of SynchroMed implantable infusion pumps due to a software problem that could cause a drug overdose or under-dose is Cla...
Federal Register notice: FDA establishes a public docket to accept comments on its ongoing efforts to enhance mechanisms for patient engagement at the...
Federal Register Notice: FDA announces a 4/5 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Ri...