A current and a retired FDA physician advisor say there should be a moratorium on agency approval of any new or reformulated opioids until FDA impleme...
CDER director Janet Woodcock says a Center reorganization involving four Offices has been approved.
Soliton files a 510(k) for the Rapid Acoustic Pulse (RAP) tattoo removal device.
Hobbled with its most restrictive distribution program, FDA approves a Sage Therapeutics NDA for Zulresso (brexanolone) intravenous injection for trea...
Attorney Sara Koblitz says it shouldnt have required litigation to force FDA to respond fully to issues raised by Vanda over animal trials for its tra...
Oregon attorney general Ellen Rosenblum says Pfizer is paying $975,000 to settle state charges it distributed misleading marketing materials and coupo...
A Dallas federal court sentences a Shanghai, China business owner to 18 months imprisonment and one year of supervised release in connection with a sc...
Two stakeholders ask FDA for clarifications and changes to a draft guidance on content of premarket submissions for managing cybersecurity in medical ...