FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Neo-Tee T-Piece Resuscitators Recalled

Mercury Medical recalls its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the requi...

latest-news-card-1
Biologics

Guide on Reducing Sepsis from Cell/Tissue Products

FDA posts a final guidance entitled Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissue...

latest-news-card-1
Human Drugs

Senators Urge PhRMA to Support DTC Advertising Bill

Senators Chuck Grassley (R-IA) and Dick Durbin (D-IL) urge the Pharmaceutical Research and Manufacturers of America to support their bipartisan Drug-p...

latest-news-card-1
Human Drugs

Inhibikase Therapeutics Pulls Plug on Parkinsons Drug

Inhibikase Therapeutics pauses further development of risvodetinib and its use in untreated Parkinsons disease due to disappointing Phase 2 study data...

latest-news-card-1
Medical Devices

Nova Bio Recalls Glucose Meters

Nova Biomedical recalls its StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect g...

latest-news-card-1
Human Drugs

Roche Sexual Disease Assay Panels Cleared

FDA clears a Roche 510(k) clearance for its cobas liat sexually transmitted infection multiplex assay panels.

latest-news-card-1
Human Drugs

Trial Speed Seen as Key to Accelerated Approvals

In an online post, three Hyman, Phelps attorneys say two new FDA guidances show how the agency plans to enforce its requirement that confirmatory tria...

latest-news-card-1
Human Drugs

Merck Stopping Winrevair Trial as Benefit Is Already Seen

Mercks ends the HYPERION trial of Winrevair early due to positive results from earlier trials so all participants can receive the drug.

latest-news-card-1
Human Drugs

Multiple Violations Cited at ProRx Outsourcing Facility

FDA warns Exton, PA-based ProRx about multiple violations in its production of drugs as an outsourcing facility.

latest-news-card-1
Medical Devices

Cybersecurity Vulnerabilities in 2 Patient Monitors

An FDA safety communication warns about cybersecurity vulnerabilities in Contec and Epsimed patient monitors.