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Increased availability of NIOSH approved respirators to healthcare personnel

March 3, 2020 Drug & Device Advisory Group Link and Learn Increased availability of NIOSH approved respirators to healthcare personnel FDA and CDC take action to increase access to respirators, including N95s, for health care personnel FDA-CDC collaboration to prioritize access to needed medical products through Emergency Use Authorization (EUA)  Certain industrial respirators during the …

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FDA Databases for Post-Approval Requirements

February 15, 2016 Drug & Device Advisory Group Link and Learn FDA Databases for Post-Approval Requirements   WHAT: Database for  oversight and tracking Studies, Requirements and Commitments postapproval. WHY: Need for oversight. Drug studies, mandated as condition of approval (accelerated approval) or for improving prescribing and use, quality and consistency. Device studies mandated as condition …

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FDA News: AAMI Technical Information Report, Fraudulent Cancer Products

May 1, 2017 Drug & Device Advisory Group FDA Briefs FDA News: AAMI Technical Information Report, Fraudulent Cancer Products FDA BRIEF: Week of April 24, 2017 AAMI Technical Information Report on “Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.” FDA + Association for the Advancement of Medical Instrumentation (AAMI) report Applies to medical …

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Drug Safety Podcasts for Healthcare Professionals

August 11, 2015August 11, 2015 Drug & Device Advisory Group Link and Learn Drug Safety Podcasts for Healthcare Professionals Division of Drug Information has posted new Drug Safety Podcasts for Healthcare Professionals. Click on the following links to read transcripts and listen to podcasts. FDA evaluating the potential risks of using codeine cough-and-cold medicines in …

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Cures Web Page

July 10, 2017 Drug & Device Advisory Group Link and Learn Cures Web Page Cures Web Page The 21st Century Cures Act (Cures Act) signed into law on December 13, 2016 Help accelerate medical product development Bring new innovations to patients faster and more efficiently Incorporate patient perspectives into the development of medical products Modernize …

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COVID-19 News: COVID Plus monitor, BioFire respiratory panel, Screening vs Diagnostic Testing, Cure ID App

March 29, 2021 Drug & Device Advisory Group FDA Briefs COVID-19 News: COVID Plus monitor, BioFire respiratory panel, Screening vs Diagnostic Testing, Cure ID App COVID PLUS Monitor Tiger Tech Solutions, Inc. INDICATION FOR USE: Non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation. ADDRESSING UNMET …

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