Tag Archive: regulatory

Aug 05 2020

New FDA Gudiances for July 2020 and Upcoming Advisory Committee Meetings

  By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020 Multiple Function Device Products: Policy and Considerations – Final Guidance 29 …

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Dec 20 2019

What’s New Health Canada? November 2019 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 – Update to Clinical Trial Site Information Form 29 November …

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Mar 17 2015

Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

How oversight would change after FDA finalizes LDT guidance

Dr. Jack Snyder, RAC, DABT, CPI, CPE CATO Research Washington “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (issued Oct. 3, 2014) On October 3, 2014, FDA issued draft guidance entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” If the …

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