FDA updates a Web page with enhancements to the CDRH electronic medical device reporting system.
The Medical Device Innovation Consortium launches an initiative to improve the accuracy of next-generation sequencing-based cancer diagnostics.
FDA commissioner Robert Califf discusses the agencys future actions in key priorities including evidence generation and accelerating progress against ...
Moderna submits an EUA for a BA.4/BA.5 Omicron-targeting bivalent booster vaccine that could be available early next month.
Essilor International (Dallas, TX) agrees to pay $16.4 million to resolve allegations that it violated the False Claims Act by paying eye care provide...
Federal Register notice: FDA announces a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting.
Federal Register notice: FDA posts a notification that OMB has approved 11 recent information collections.
CDER plans to review and discuss its proposed Quality Management Maturity program at an 11/2 advisory committee meeting.
