Tag Archive: Regulatory Authorities

Mar 04 2020

New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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Mar 04 2020

What’s New Health Canada? January and February 2020 Updates

  By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in:   Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada   Type of Update and Link Date Posted Notice: Product Monograph Implementation Plans 13 January 2020 …

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