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...
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 ...
FDA warns Pfizer Healthcare India about a CGMP violation in its production of finished drugs.
CME America recalls the BodyGuard Infusion Pump Systems because the pumps may under or over infuse medications.