FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Medical Devices

ArjoHuntleigh Polska Recalls Floor Lifts

ArjoHuntleigh Polska recalls its Sara Plus floor lift following several complaints of smoke or flames coming out of the device.

Federal Register

Guide on Prostate Cancer Drug Development

Federal Register notice: FDA makes available a final guidance entitled Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues....

Human Drugs

FDA Extends Shelf Life for Lillys Bentelovimab

FDA extends the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is cur...

Medical Devices

FDA Approves Medtronic In.Pact 018 Balloon Catheter

FDA approves Medtronics In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the interventional treatme...

Federal Register

HHS Withdraws SUNSET Final Rule

Federal Register notice: Health and Human Services withdraws a final rule entitled Securing Updated and Necessary Statutory Evaluations Timely (SUNSET...

FDA General

Senate Unveils User Fee Reauthorization Bill With FDA Enhancements

The Senate Health, Education, Labor and Pensions Committee introduces a bill to reauthorize FDAs user fee programs in addition to provisions to streng...

Human Drugs

Researchers See Breakthrough Therapy Value in Cancer

A Friends of Cancer Research-funded analysis shows a positive correlation between drugs receiving a breakthrough therapy designation for non-small cel...

Human Drugs

OTC External Analgesic Product Labeling Petition

Attorney Nancy Taylor asks FDA to take steps to increase the use of OTC external analgesics in pain management.

Medical Devices

Abbott Dragonfly Catheter Recall is Class 1

FDA says an Abbott recall of specific lots of its Dragonfly OpStar imaging catheter due to a potential loose marker band is Class 1.

Federal Register

Panel to Review Skin Lesion AI Technology

Federal Register notice: FDA announces a 7/28-29 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting that will...