Federal Register notice: FDA announces that it received a petition requesting exemption from the premarket notification requirements for the generic d...
OGD Office of Research and Standards director Robert Lionberger describes steps FDA has taken to foster the development of complex generic drugs.
FDA says Sanofi did not submit sufficient data to justify approving an Aubagio sNDA for an indication for pediatric patients with relapsing forms of m...
FDA approves Stratatechs StrataGraft, a cellularized scaffold for treating adult patients with certain thermal burns.
Federal Register notice: FDA announces a 7/14 meeting of it Medical Devices Advisory Committees Gastroenterology and Urology Devices Panel that will r...
Federal Register notice correction: FDA corrects a 2/12/2018 Federal Register notice to revise the regulatory review period for Mercks Bravecto (flura...
Viona Pharmaceuticals recalls two lots of diabetes drug metformin HCl 750mg because the product was found to contain levels of human carcinogen nitros...
The Justice Department indicts generic drug manufacturer KVK-Tech and two executives on charges of defrauding FDA based on their alleged distribution ...