FDA Related News

Federal Register

Animal Drug Regs Amended on Review Actions

Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...

Human Drugs

New CDER Web Page Housing EUA Docs/Requirements

CDER creates a new Web page to house scientific review documents supporting emergency use authorizations for drug and biological therapeutic products,...

FDA General

Becerra HHS Confirmation May Free Up FDA Nomination

The U.S. Senate confirms California attorney general Xavier Becerra as HHS secretary, a move that could expedite the nomination of an FDA commissioner...

Medical Devices

Life Spine Prolift Wedge Clearance

FDA clears a Life Spine 510(k) for the Prolift Wedge Expandable Spacer System.

Medical Devices

FDA Says ACIST Recall of Kodama Catheter is Class 1

FDA says the ACIST recall of 490 units of its Kodama intravascular ultrasound catheter is Class 1.

Human Drugs

Tremfya Arthritis Benefits Last Through 2 Years: Janssen

Janssen says treatment benefits from its Tremfya in psoriatic arthritis have been shown to last two years.

Human Drugs

Students Suggest Ways to Improve FDA Draft Antisense Oligonucleotide Guidance

Three students in a Duke University Science Regulation Lab course offer suggestions for FDA to improve a draft guidance on administrative and procedur...

Human Drugs

GSK Opens Phase 3 Asthma Study Using Anti-IL-5 Treatment

GlaxoSmithKline launches a Phase 3 trial of its GSK294 biologic to treat eosinophilic asthma.

Medical Devices

FDA Grants De Novo for Covid Diagnostic

FDA grants BioFire Diagnostics a De Novo marketing authorization for the BioFire Respiratory Panel 2.1, a diagnostic test for the simultaneous qualita...

FDA Touts Alternative Inspection Oversight Results

FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Judy McMeekin say the agency has succeeded in using alternate...