FDA Related News

Human Drugs

FDA Developing Ways to Predict Drug Effects Before Trials

A CDER Regulatory Science Impact Story describes Center researchers efforts to develop microengineering human cellular system to predict drug toxicity...

Human Drugs

FDA Expanding Real-World Evidence Demonstration Project

FDA expands its RCT DUPLICATE demonstration project to use real-world evidence to estimate results of seven Phase 4 trials.

Medical Devices

FDA Denies Helius De Novo App for Neuromodulation Stimulator

FDA denies a Helius Medical Technologies de novo marketing request for its Portable Neuromodulation Stimulator device for treating patients with chron...

Human Drugs

Bedfont 510(k) Cleared for Carbon Monoxide Monitor

FDA clears a Bedfont 510(k) for its ToxCO carbon monoxide (CO) breath analysis monitor which determines levels of carbon monoxide poisoning.

Companies, Individuals Settle FTC Geniux Charges

The Federal Trade Commission says corporate and individual defendants have resolved cognitive improvement supplement deceptive marketing charges.

Medical Devices

Dont Use Uncleared, Unapproved Devices for Concussion: FDA

FDA cautions against using unapproved or uncleared medical devices to diagnose, treat, or manage head injuries, including concussions.

Invidior Indicted for Illegal Suboxone Marketing

A federal grand jury indicts Invidior for illegal misleading marketing of its Suboxone Film opioid-addiction treatment.

Human Drugs

Braeburn Wants Sublocade Orphan Designation Dropped

Braeburn asks FDA to revoke the orphan drug designation for Invidiors opioid use disorder drug Sublocade.

Human Drugs

Zogenix Given Refusal to File on Fintepla NDA

FDA issues Zogenix a refusal to file letter for its for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome.

Medical Devices

Innoblative Designs Sira RFA Electrosurgical Device Cleared

FDA clears an Innoblative Designs 510(k) for Sira RFA Electrosurgical Device, a novel radiofrequency ablation applicator that supplies energy for use ...