FDA Related News

Marketing

Comments on OPDP Endorser Status Research

Two stakeholders raise concerns with proposed direct-to-consumer advertising research into celebrity endorsements.

Minor Revisions Suggested for FDA Bridging Guidance

AdvaMed proposes minor revisions to an FDA draft guidance on combination product bridging.

Human Drugs

White House Continues Effort to Speed Virus Therapies

The Trump administration continues to put political pressure on FDA to speed access to potential coronavirus treatments.

Medical Devices

Medtronic Recalls Pipeline Flex Embolization Device

Medtronic recalls (Class 1) its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk...

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 ...