Senator Patrick Leahy (D-VT) introduces legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies ...
FDA posts a three-item Form 483 after an inspection at Lupins Goa, India drug manufacturing facility found GMP problems.
Federal Register notice: FDA announces a 5/18 joint Pediatric Advisory Committee and Pediatric Ethics Subcommittee meeting to discuss a referral by an...
Federal Register notice: FDA seeks comments on an information collection extension for Good Laboratory Practice Regulations for Nonclinical Studies 2...
FDA launches a new medical device Web page, Use of Symbols in Labeling, to assist the public in understanding the Use of Symbols in Labeling final rul...
FDA clears a Faxitron 510(k) for the LOCalizer, a wireless radiofrequency identification breast lesion localization system.
FDA approves a Radius Health NDA for Tymlos (abaloparatide) injection for treating postmenopausal women with osteoporosis at high risk for fracture.
Federal Register notice: CDER and CDRH announce a two-day (5/9-10) public conference entitled FDA Small Business and Industry Assistance Regulatory Ed...