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Medical Devices

FDA Update on Paclitaxel-Coated Balloons/Stents

FDA launches a new Web page about the safety of paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions...

Medical Devices

Let Juries Hear 510(k) Evidence: Attorney

Attorney Phil Goldberg says the New Jersey Supreme Court should decide in two pelvic mesh liability cases that juries should hear evidence of FDAs act...

Human Drugs

FDA Providing Drug Info to Pregnant Women

FDA updates consumers on its efforts to make more prescription drug information available to pregnant and breastfeeding women.

PhRMA Comments on Safety Reporting Guidance

PhRMA says it appreciates the FDA approach in a draft guidance on investigator responsibility for safety reporting for investigational drugs and devic...

Medical Devices

Sales Rep Settles False Claims Case

The Justice Department says a self-employed medical device sales rep has agreed to pay $100,000 to resolve allegations he assisted in causing the subm...

Federal Register

Eating Disorder Tool Put in Class 2

Federal Register notice: FDA classifies the conditioning tool for eating disorders into medical device Class 2 (special controls).

Federal Register

Class 2 for Esophageal Tissue Characterization

Federal Register notice: FDA classifies the esophageal tissue characterization system into Class 2 (special controls).

Human Drugs

FDA Says More CBD Info Needed

A CDER executive tells a hemp industry conference that FDA still needs more information before it can address the use of CBD in food and dietary suppl...

Human Drugs

2 Former Immunomedics Officials Arrested

The Justice Department says two former Immunomedics officials have been arrested on charges of insider trading.

Medical Devices

CoreLink 510(k) Spinal Fixation System

FDA clears a CoreLink 510(k) for its CentraFix Midline Spinal Fixation System.