FDA Related News

Human Drugs

CDER Reorganization Clears Congress

CDER director Janet Woodcock says Congress has approved the Centers reorganization plan and it is being implemented.

Human Drugs

Advisors Asked About Pediatric Singulair Neuropsych Events

FDA asks members of two advisory committees for input on labeling options and communications strategies to address neuropsychiatric side events of Mer...

Human Drugs

Janssen sBLA for Combination Darzalex Use in Myeloma

FDA approves a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for tr...

Human Drugs

Apotex Recalls Some OTC Ranitidine Tablets

FDA announces an Apotex recall of two strengths of generic Zantac labeled for Walgreens, Walmart, and Rite-Aid due to possible NDMA contamination.

Human Drugs

FDA Guidance on REMS Changes Explained

Three Drinker Biddle attorneys caution drug companies to consult a recent FDA final guidance on REMS modifications and revisions to be sure distributi...

Medical Devices

Siemens AI-Rad Chest CT Software Cleared

FDA clears a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings artificial intelligence ...

Human Drugs

FDA Expands Mavyret Indication

FDA approves an expanded indication for AbbVies hepatitis C drug Mavyret.

Medical Devices

Device Breakthrough Designation May be Made Public: Shuren

CDRH director Jeffrey Shuren says FDA would like to hear from companies if they would be comfortable having the agency make medical device breakthroug...

Medical Devices

Abbott Recharge-Free Neurostimulation Device OKd

FDA approves Abbotts Proclaim XR recharge-free neurostimulation system for people with chronic pain.

Treatment Effects Higher in Accelerated Approvals: Study

Researchers say the magnitude of treatment effects is higher among drugs and medical devices approved through accelerated pathways than in those for w...