Three academic researchers say the FDA de novo medical device pathway has the potential to attract innovators who want to define new categories of dev...
CDER Office of Communications social scientist Alexandria Smith says the Center tests some communications intended for consumers or healthcare profess...
Federal Register notice: FDA seeks comments concerning recommendations by the World Health Organization to impose international manufacturing and dist...
Philips North America recalls its BrightView computed tomography gamma camera system because of the risk of the detector unexpectedly falling.
FDA sets a 10/8 PDUFA action date for a Bristol Myers Squibb sNDA for Opdivo to treat some non-small cell lung cancers.
Amneal Pharmaceuticals resubmits an NDA for IPX203, a novel oral formulation of carbidopa/levodopa extended-release capsules for treating Parkinsons d...
Four Hogan Lovells attorneys say medical device companies should begin now to prepare for the implementation of FDAs new Quality Management System Reg...
Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says FDA and EMA are evaluating a new pilot parallel sci...
