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Medical Devices

FDA Safety Alert on Laws PPE of Motion Gowns

FDA alerts healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-based Laws of Motion PPE...

Federal Register

Draft Guide on CNS Cancer Drugs

Federal Register notice: FDA makes available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases.

Human Drugs

Cassiopea First-in-Class Acne Drug Approved

FDA approves a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older.

Human Drugs

Teva Charged in Generic Drug Price Fixing

The Justice Department charges Teva as part of a probe into generic drug price-fixing.

Medical Devices

Braun SpaceStation MRI Cleared

FDA clears a B. Braun Medical 510(k) for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within MRI...

Medical Devices

EUA for Abbott BinaxNOW Covid Antigen Test

FDA grants an emergency use authorization for the Abbott BinaxNOW Covid-19 rapid low-cost antigen test.

Medical Devices

FDA Approves FoundationOne Liquid Biopsy Test

FDA approves Foundation Medicines FoundationOne Liquid CDx biopsy test.

Medical Devices

Public Citizen Sues FDA for Seprafilm Petition Answer

Public Citizen asks the DC federal court to compel FDA to respond to its 2015 petition asking the agency to ban Baxters Seprafilm.

Medical Devices

Mitigate Risk from IoT Vulnerability: Post

A Security Intelligence post describes an Internet of Things computer module vulnerability that could adversely affect medical devices.

Human Drugs

FDA, LUNGevity Foundation Patient Experience Study

The FDA Oncology Center of Excellence and LUNGevity Foundation launch a multi-year study of the real-world experiences of lung cancer patients.