FDA informs Novartis of extension to US regulatory review period for QAB149, a novel once-daily bronchodilator for ...
Novartis International AG / FDA informs Novartis of extension to US regulatory review period for QAB149, a novel once-daily bronchodilator for treatment of COPD Processed and transmitted by Thomson Reuters. The issuer is solely responsible for

FDA lifts warnings against 2 Medtronic plants, clearing way for new product approvals
WASHINGTON - Medtronic Inc., the world's largest medical device company, said Wednesday it has resolved two warning letters from the Food and Drug Administration over lax oversight at two manufacturing plants, clearing the way for new product approvals.

Speed of FDA approvals a starting point for new Congressional review
FDA approvals are going to remain an issues for medical device manufacturers. Congressional leaders reviewing the Medical Device User Fee and Modernization Act say recent reforms have been overstated and that concerns over safety and increased scrutiny are wrongheaded.