President-elect Donald Trumps transition team reportedly adds former FDA deputy commissioner Scott Gottlieb to the short list of candidates for the to...
Bristol-Myers Squibb enters into a $19.5 million settlement agreement with 43 states to resolve allegations the company used false and misleading repr...
Five stakeholders reiterate positions and add new insights from an FDA meeting on progress made toward implementing product identification requirement...
Stakeholders say they appreciate an FDA draft guidance on when medical device software changes require a new 510(k) and offer proposed revisions.
FDA issues a guidance to help trading partners identify a suspect product and notify FDA and other trading partners.
FDA clears an Exact Imaging 510(k) for its ExactVu micro-ultrasound system for urological procedures.
Stakeholders voice support for International Conference on Harmonization draft guidelines on multi-region clinical trials and make specific suggestion...
The acting solicitor general says the Supreme Court should hear appeals by Amgen and Sandoz involving two key related provisions of the Biologics Pric...