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TXT FDA Safety Alert on Laws PPE of Motion Gowns [2644 Words] [ Price : $8.95]
FDA alerts healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-based Laws of Motion PPE.com because they may not provide their labeled level of protection, including fluid barrier protection.
08/28/2020
 
 
TXT Patient Engagement Advisory Panel on Device AI [88 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 10/22 Patient Engagement Advisory Committee meeting.
08/27/2020
 
 
TXT Draft Guide on CNS Cancer Drugs [116 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases.
08/27/2020
 
 
TXT Cassiopea First-in-Class Acne Drug Approved [126 Words] [ Price : $8.95]
FDA approves a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older.
08/27/2020
 
 
TXT Teva Charged in Generic Drug Price Fixing [2783 Words] [ Price : $8.95]
The Justice Department charges Teva as part of a probe into generic drug price-fixing.
08/27/2020
 
 
TXT Braun SpaceStation MRI Cleared [188 Words] [ Price : $8.95]
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 suites.
08/27/2020
 
 
TXT EUA for Abbott BinaxNOW Covid Antigen Test [2728 Words] [ Price : $8.95]
FDA grants an emergency use authorization for the Abbott BinaxNOW Covid-19 rapid low-cost antigen test.
08/27/2020
 
 
TXT FDA Approves FoundationOne Liquid Biopsy Test [2634 Words] [ Price : $8.95]
FDA approves Foundation Medicine’s FoundationOne Liquid CDx biopsy test.
08/27/2020
 
 
TXT Public Citizen Sues FDA for Seprafilm Petition Answer [2764 Words] [ Price : $8.95]
Public Citizen asks the DC federal court to compel FDA to respond to its 2015 petition asking the agency to ban Baxter’s Seprafilm.
08/27/2020
 
 
TXT Mitigate Risk from IoT Vulnerability: Post [2763 Words] [ Price : $8.95]
A Security Intelligence post describes an Internet of Things computer module vulnerability that could adversely affect medical devices.
08/27/2020
 
 
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