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FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Members Sought for Mammography Panel

Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advisory Committee.

Federal Register

Class 2 for Intraoperative Orthopedic Strain Sensor

Federal Register notice: FDA classifies the intraoperative orthopedic strain sensor into Class 2 (special controls).

Federal Register

Trunk/Limb Electrical Stimulator in Class 2

Federal Register notice: FDA classifies the trunk and limb electrical stimulator to treat headache into Class 2. (special controls).

Human Drugs

Lilly EUA for Monoclonal Antibodies Expanded

FDA revises an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patients than previously au...

FDA General

No Imminent Retirement for Woodcock

FDA acting commissioner Janet Woodcock plans to play a senior role at the agency if FDA commissioner nominee Robert Califf is confirmed by the Senate.

Medical Devices

Congress Should Revamp 510(k) Process: Opinion

A Yale and Harvard opinion piece says Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee pro...

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.