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AdvaMed proposes minor revisions to an FDA draft guidance on combination product bridging.
The Trump administration continues to put political pressure on FDA to speed access to potential coronavirus treatments.
Medtronic recalls (Class 1) its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk...
FDA grants an emergency use authorization for the NeuMoDx SARS-CoV-2 assay that produces results in 80 minutes.
Federal Register notice: FDA makes available a guidance on notifying FDA about a permanent discontinuance or interruption in product manufacturing.
Federal Register notice: FDA announces a 6/8 ophthalmic devices advisory committee meeting that will review a Refocus Group PMA for the VisAbility Mic...