FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Medical Devices

Tytek Medical Recalls PneumoDart

FDA classifies as Class 1 a Tytek Medical recall of its PneumoDart, a compact device used to remove air from the pleural cavity.

Human Drugs

FDA Asks Eisai to Withdraw Belviq from Market

FDA says Eisai has submitted a request to voluntarily withdraw its Belviq weight-loss drug from the market after FDA found an increased risk of cancer...

Human Drugs

Man Sentenced to 7 Years Over Unapproved Drug

Florida federal judge Paul G. Byron sentences Barry Clint Wright (Monroe, NC) to seven years in federal prison for introducing an unapproved and misbr...

FDA General

FDA Justifies FY 2021 $6.2 Billion Budget Request

FDA sends Congress its justification for a $6.2 billion FY 2021 budget request.

Human Drugs

FTC Sues 2 Companies Over Joint Pain Products

The Federal Trade Commission sues two companies to stop them from falsely claiming that their pills are scientifically proven to alleviate joint pain ...

Human Drugs

CDER Launches Controlled Substances Program

CDER launches a Controlled Substances Program to coordinate Center activities and emerging issues around various controlled substances.

Medical Devices

New 510(k) Review Learning Modules

CDRH releases three new learning modules on aspects of the 510(k) third-party review program.

Medical Devices

Workshop on DNA-based Cancer Screening Tests

FDA announces a 3/9 workshop on Detecting Circulating Tumor DNA for Cancer Screening.

Medical Devices

Medtronic MiniMed Pump Recall is Class 1

FDA says the Medtronic recall of its MiniMed 600 Series insulin pumps, due to a missing or broken retainer ring, is Class 1.

Medical Devices

Peripheral Vascular Atherectomy Device Guidance

FDA issues a guidance on 510(k) submissions for peripheral vascular atherectomy devices.