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Medical Devices

Quality System Violations at Vilex

FDA warns Vilex in Tennessee about Quality System violations in its work involving Class 1 and 2 orthopedic implants and tools.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Diamond Wipes International, Labocont Industrial, Malladi Drugs & Pharmaceuticals and V...

Medical Devices

Life Spine Lumbar Fusion Spacer System Cleared

FDA clears a Life Spine 510(k) for the Plateau-LO Insert and Rotate Spacer System and its use in micro-invasive lumbar interbody fusion procedures.

Federal Register

Comments Extended on Homeopathic Drug Guidance

Federal Register notice: FDA extends by 60 days the comment period on a 12/20/2017 Federal Register notice entitled Drug Products Labeled as Homeopath...

Federal Register

Guide on Small Business Determination

Federal Register notice: FDA makes available a draft guidance on how to determine the number of employees for purposes of a small business definition....

FDA General

Amazon Hires Former FDA Chief Information Officer

Amazon hires former FDA chief health information officer Taha Kass-Hout, a sign that the online retailing behemoth may be challenging Google and its X...

Federal Register

Public Workshop on Pathways to Global Unity

Federal Register notice: FDA announces a 6/11-12 public workshop on Pathways to Global Unity.

Human Drugs

House Again Takes Up Right-to-Try; 4 Ex-FDA Heads Oppose

Four former FDA commissioners issue a brief joint statement opposing a right-to-try bill as House Republicans prepare to advance the measure through t...

Human Drugs

FDA Posts 1st Clinical Study Report in Transparency Pilot

A new FDA drug approval transparency pilot program releases the first Clinical Study Report that provides more background on why the agency recently a...

Human Drugs

FDA Accepts pSivida NDA for Durasert

FDA accepts a pSivida Corp. NDA for Durasert three-year treatment for posterior segment uveitis.