Tag Archive: Cato Research

Apr 06 2020

New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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Feb 04 2020

New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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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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Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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Oct 18 2019

What’s New Health Canada? August and September 2019 Updates

What’s New Health Canada? By Christine Straccini, B.Sc., C.C.R.P., Regulatory 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 Updated notice: Mandatory Use of the Electronic …

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Apr 10 2019

2019 March FDA Guidances

Special Interest Guidances/Information Date Posted Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice – Final Guidance 27 Mar 2019 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Final Guidance 25 Mar 2019 Rare Diseases: Natural History Studies …

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Mar 22 2019

Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?

By Greg Hileman, Ph.D, Senior Director of Regulatory Affairs and Principle Regulatory Scientist at Cato Research   On March 5, the FDA approved Spravato (esketamine) nasal spray, for use in conjunction with an oral antidepressant for treatment-resistant depression. Esketamine is the s-enantiomer of ketamine, approved in the 1970’s as an anesthetic, but used off-label since …

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Mar 20 2019

FDA Approval of New Opioid Drug (DSUVIATM) Stirs Controversy – Is it Necessary or Not?

By Dieanira Erudaitius, Ph.D., Scientist at Cato Research The United States Food and Drug Administration (FDA) granted approval of the opioid analgesic DSUVIATM on 02 November 2018.[[1]] Its intended use is for adults only where acute pain management has no alternative treatment other than an opioid analgesic. DSUVIATM is a sublingual tablet containing sufentanil as …

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Mar 18 2019

New FDA Guidances for February 2019

By Joanne McNelis, Ph.D., RAC (US), Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in December are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Evaluation of Bulk Drug Substances Nominated for Use in …

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Mar 05 2019

TRAUMATIC BRAIN INJURY

By Mabel Ruscitti and Arnavaz Eduljee, Cato Research AWARENESS: Traumatic Brain Injury (TBI) occurs from a blow, jolt, bump or a penetrating object to the head.[1, 2] Traumatic brain injury can lead to brain cell death, inflammation, edema, hemorrhage, and severe disruption to normal brain cell function.  Concussion injury frequently results in persistent functional impairment …

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