FDA proposes to reclassify two types of hepatitis C diagnostic tests from Class 3 to Class 2 with special controls.
Federal Register notice: FDA amends certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k))...
FDA asks manufacturers of all Rx and OTC ranitidine products to remove them from the market due to NDMA contamination.
Federal Register notice: FDA amends its medical device regulations to reflect changes to CDRHs organizational structure, including the reorganization ...
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions made during the first quarter of this fiscal ye...
The Wiley Rein law firm asks FDA to rescind its approval of OTC status for diclofenac gel 1% unless revisions are made to the labeling to cover safety...
Two stakeholders raise concerns with proposed direct-to-consumer advertising research into celebrity endorsements.
AdvaMed proposes minor revisions to an FDA draft guidance on combination product bridging.