FDA posts an updated guidance clarifying when clinical decision support software functions fall outside the definition of a regulated medical device.
An industry consultant says reduced FDA staffing levels and high turnover are extending regulatory timelines and forcing drug developers to invest mor...
Axios reports that the vice chair of the CDC Advisory Committee on Immunization Practices says the Pfizer and Moderna Covid mRNA vaccines should be re...
CDRH reports on its 2025 MDUFA 5 activities to promote international harmonization.
A Congressional Research Service backgrounder explains options Congress could consider to resolve some issues with the skinny label provision in the W...
FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth f...
Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firms petition seeking restrictions on approval of gener...
The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authorizations in history.
