FDA Related News

Human Drugs

InControl Medical OTC Incontinence Device Cleared

FDA clears an InControl Medical 510(k) for the Attain, an over-the-counter non-implantable muscle stimulator designed for at-home use to help treat wo...

Medical Devices

Masimo CO-Oximeter Cleared by FDA

FDA clears a Masimo 510(k) for the Rad-67 Pulse CO-Oximeter with Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusab...

Human Drugs

Praise for FDA Patient Experience Draft Guidance Draft

Stakeholders praise FDA for a draft guidance on how patient advocacy groups may submit their own proposed draft guidances to make use of patient exper...

Federal Register

Panel to Discuss Rabies Virus Monoclonal Antibodies

Federal Register notice: FDA announces a 4/25 Antimicrobial Drugs Advisory Committee meeting to discuss approval of rabies virus monoclonal antibodies...

Federal Register

Draft Guide on Disease Natural History Studies

Federal Register notice: FDA makes available a draft guidance Rare Diseases: Natural History Studies for Drug Development.

Medical Devices

BrightWater Medical 510(k) for ConvertX Biliary Stent

FDA clears a BrightWater Medical 510(k) for the ConvertX Biliary Stent System for treating biliary obstructions.

Human Drugs

Bayer/Janssen Pay $775 Million to Settle Xarelto Claims

Bayer and Janssen Pharmaceuticals agree to pay $775 million to settle about 25,000 claims against blood thinner Xarelto (rivaroxaban) and alleged seri...

Medical Devices

Zimmer Biomet Robotic Knee Surgical Device Cleared

FDA clears a Zimmer Biomet 510(k) for the Rosa One Spine System for robotically assisted spine surgeries.

Guide on Using Standards for CBER Submissions

FDA posts a final guidance on Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation...

Federal Register

Panel to Review Chiesi Cystic Fibrosis NDA

Federal Register notice: FDA announces a 5/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review a Chiesi USA NDA for its cystic fibrosis dru...