FDA Related News

Medical Devices

Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception...

FDA General

FDA May Go Months Without Senate-Confirmed Commissioner: Analysis

An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate eff...

Human Drugs

Diamantas Touts FDA Moves to Boost U.S. Jobs

FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American workers and protecti...

Medical Devices

FDA Selects Dexcom as First Participant in Digital Health Pilot with CMS

FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot.

FDA General

FDA Reform Requires a Whole-of-System Strategy: Editorial

A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully...

FDA General

House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adopti...

Marketing

FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevention product Beyfortu...

Novo Nordisk Sues Lilly Over GLP-1 Ads

Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares the two companies GL...

Human Drugs

CGMP Issues at Indias Shimoga Chemicals

FDA warns Indias Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical ingredients.

Human Drugs

No Informed Consent in Alembic Trial

FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.