Federal Register notice: FDA classifies software applications for contraception into Class 2 (special controls).
Alnylam Pharmaceuticals says it will complete its NDA rolling submission for givosiran, indicated for treating acute hepatic porphyria after reporting...
Purdue rebuts a Massachusetts claim that it improperly marketed its opioid medications for long-term and high-dose use, citing FDA approval of the ind...
FDA releases the FDA-483 with four observations from an inspection at the Michigan Medicine drug compounding facility.
FDA warns Actavis about CGMP violations in its manufacturing of finished pharmaceuticals at a Florida facility.
RVO 2.0 recalls its Raindrop Near Vision Inlay because data from a post-approval study showed an increased risk of corneal haze associated with the de...
The Tufts Center for the Study of Drug Development reports on the growth of contract research services as part of drug development worldwide.
Apotex recalls four lots of drospirenone and ethinyl estradiol tablets because the contraceptive may contain defective blisters with incorrect tablet ...