FDA commissioner Scott Gottlieb outlines agency steps to promote medical device innovation, including one draft and two finalized guidances.
FDA clears an Ortek Therapeutics 510(k) for the Ortek ECD, a lightweight tabletop device designed as an aid for dental professionals to diagnose and m...
Federal Register notice: FDA announces support for the most current B3-format annual version of the World Health Organization Drug Global (formerly na...
Federal Register notice: FDA denies a request for a hearing and issues an order debarring Trang Doan Nguyen for five years from providing services in ...
FDA issues a Warning Letter to Magellan Diagnostics for modifying versions of two of its blood lead testing systems without the agencys required clear...
SCA Pharmaceuticals recalls all lots of several injectable products because there is a potential for them to contain microbial contamination.
A new analysis from the RAND Corporation says biosimilar approvals should help cut healthcare spending by $54 billion over the next decade.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,216 days.