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AdvaMed proposes minor revisions to an FDA draft guidance on combination product bridging.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.
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...
FDA warns Bulgarias Ficosota drug manufacturing firm about CGMP violations in its production of finished drugs.
FDA warns Trilogy Laboratories about CGMP, new drug, and misbranding violations in its production of finished drugs.
Psychiatrist David Behar petitions FDA to remove the clozapine REMS program and allow providers to use their clinical judgment in monitoring patients ...