Tag Archive: Cato Research

Jan 04

New FDA Guidances for December 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory 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 Labeling of Red Blood Cell Units with Historical …

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Dec 27

What’s New Health Canada?

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy   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 (Drugs and Biologics)   Type of Update and Link Date Posted Notice: Validation rules for …

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Dec 11

New FDA Guidances for November 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Self-Monitoring Blood Glucose Test Systems for Over-the-Counter …

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Dec 04

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

By Denis Okumu, Ph.D., Postdoctoral Fellow at Cato Research Ltd Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA) amended section 402(j) of the Public Health Service (PHS) Act[1] to require that responsible parties and/or submitters of certain applications and submissions to …

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Nov 06

New FDA Guidances for October 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Considerations for the Development of Dried Plasma …

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Oct 02

New FDA Guidances for September 2018

By Zachary Swan, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in September are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the …

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Sep 06

New FDA Guidances for August 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research   FDA draft and final guidances released from CDER, CBER, and CDRH in August are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Hematologic Malignancy and Oncologic Disease: Considerations for …

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Aug 16

New FDA Guidances for June and July 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance …

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Aug 09

Medical Devices: Clinical Trials in South Africa – Part 1

By Nicola Main, Clinical Research Manager I, Clinical Trial Operations – Rest of World Cato Research   Medical Device Workshop at MCC – 13/14 July 2017 – Summary for SACRA Members This workshop provided supporting information and explanation of items contained in the various guidelines regarding medical devices. These guidelines are in the process of being …

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Jul 12

FDA Approval of Epidiolex and the Cannabis-Based Drug Pipeline

By: Kristen Biernat, Cato Research   The Food and Drug Administration (FDA) granted approval of the cannabis-based drug Epidiolex to GW Research Ltd. (GW) on June 25, 2018.1 The FDA’s approval of Epidiolex represents two major milestones for GW: First, it is addresses the unmet need for patients with Lennox-Gastaut syndrome and Dravet syndrome, two …

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