FDA seeks to implement a novel regulatory approach for direct-to-consumer genetic health risk tests that will use flexible oversight similar to the mo...
Legislative language in an FY 2018 Defense Department spending bill gives the military the authority to approve the emergency use of medical products ...
Federal Register notice: FDA seeks comments on an information collection extension provision under its Guidance for Industry: Substantiation for Dieta...
Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and Budget.
In a move that may signal the agencys increasing reliance on real world data, FDA reverses its decision to require TherapeuticsMD to submit additional...
FDA Review posts FDA-related Federal Register notices for the week ending 11/3/2017.
CDRH Office of Compliance director Robin Newman leaves the agency to pursue an undisclosed opportunity.
FDA clears a Medacta International 510(k) for its 3DMetal Tibial Cones for knee revision surgery.