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Medical Devices

EUA for NeuMoDx Covid-19 Assay

FDA grants an emergency use authorization for the NeuMoDx SARS-CoV-2 assay that produces results in 80 minutes.

Federal Register

Guide on Product Manufacturing Discontinuance

Federal Register notice: FDA makes available a guidance on notifying FDA about a permanent discontinuance or interruption in product manufacturing.

Federal Register

Ophthalmic Panel Review VisAbility Micro Insert PMA

Federal Register notice: FDA announces a 6/8 ophthalmic devices advisory committee meeting that will review a Refocus Group PMA for the VisAbility Mic...

Human Drugs

CGMP Violations at Bulgarias Ficosota

FDA warns Bulgarias Ficosota drug manufacturing firm about CGMP violations in its production of finished drugs.

Human Drugs

Multiple Violations at Trilogy Laboratories

FDA warns Trilogy Laboratories about CGMP, new drug, and misbranding violations in its production of finished drugs.

Human Drugs

End Clozapine REMS: Psychiatrist

Psychiatrist David Behar petitions FDA to remove the clozapine REMS program and allow providers to use their clinical judgment in monitoring patients ...

Human Drugs

Pfizer Healthcare India CGMP Violation

FDA warns Pfizer Healthcare India about a CGMP violation in its production of finished drugs.

Medical Devices

CME BodyGuard Infusion Pump Recalled

CME America recalls the BodyGuard Infusion Pump Systems because the pumps may under or over infuse medications.

Human Drugs

PhRMA Rare Disease Day Comments

PhRMA submits additional comments on the FDA 2/24 Rare Disease Day public meeting.

Human Drugs

Novartis Not Penalized for Zolgensma Violations

FDA ends its probe of Novartis Zolgensma data manipulation and waives any regulatory action against the company.