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Insulet Recalls Omnipod DASH Insulin Manager

[ Price : $8.95]

Insulet recalls (Class 1) its Omnipod DASH Insulin Management Systems Personal Diabetes Manager after receiving reports battery is...

Cosmetic Solutions CGMP, Unapproved Drug Violations

[ Price : $8.95]

FDA warns Boca Raton, FL-based Cosmetic Solutions about CGMP and unapproved new drug violations in its manufacturing of finished d...

Drug QA Inspections Up 40%: Report

[ Price : $8.95]

The Office of Pharmaceutical Quality FY 2023 annual report says drug quality assurance inspections were up 40% over FY 2022 and mu...

Upcoming CDRH eMDR Enhancements

[ Price : $8.95]

FDA lists three planned 2024 enhancements to the CDRH electronic medical device reporting system.

Medline Recalls Sub-G Endotracheal Tube

[ Price : $8.95]

Medline Industries recalls its Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube.

Concerns With Alzheimers Drug Development Guidance

[ Price : $8.95]

Biogen and Public Citizen call on FDA to address issues in its draft guidance on developing drugs to treat early Alzheimers diseas...

Women Underrepresented in Device Trials: Research

[ Price : $8.95]

Israeli researchers say more effort must be made to increase the number of women enrolled in medical device clinical trials.

Ipsen Gains Accelerated OK for Iqirvo

[ Price : $8.95]

FDA grants Ipsen accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis in combinati...

Obstetrics/Reproductive Advisory Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an ad...

Arthritis Advisory Panel Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Arthritis Advisory Committee for an additional two years.