Category Archive: Cato Research

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 12 2019

Lets talk about Patient Engagement

patient engagement , clinical trials

Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are becoming longer and more expensive and many of them fail to meet their recruitment goal, patient engagement plays a key role in the success of a clinical trial. But what is exactly patient engagement and …

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Feb 19 2019

Pharmacogenetics- Tailoring your product to fit the genes

Pharmacogenetics – Tailoring your product to fit the genes By Carron Sher, M.D. Senior Clinical Research Physician   John received anti-malarial therapy and developed severe hemolytic anemia.  He was diagnosed as having G6PD deficiency. Sally was started on warfarin and there was a problem in achieving the desired therapeutic response.  She was diagnosed as having …

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Feb 15 2019

Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

By: Juliati Rahajeng, Ph.D., Clinical Strategy Scientist at Cato Research, and Dieanira Erudaitius, Ph.D., Scientist at Cato Research   A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable products regulated under the Biosimilar User Fee Act (BsUFA) was published in June 2018. It describes …

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Feb 08 2019

Big Data, RWE, and AI Made Simple

By Hadas Jacoby Adani, Marketing Manager, Israel, Cato Research Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands …

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Jan 24 2019

Cervical Health Awareness Month – Cervical Cancer: Prevention, Detection, Development

By Amy Lane, Scientist at Cato Research   As Cervical Health Awareness Month comes to a close, it is a good time to review the state of cervical cancer, what you can do personally, and what is happening in drug development. Cervical cancer is most often caused by the human papillomavirus (HPV) and generally develops …

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Aug 16 2018

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 15 2018

What’s New Health Canada?

  By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy   What’s New in: Therapeutic Products Directorate:   Biologics and Genetic Therapies Directorate:   Medical Devices:   Natural and Non-prescription Health Products Directorate:     Health Canada New Guidance Documents (Drugs and Biologics)   Health Canada Guidance Type Date Posted …

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Aug 09 2018

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 2018

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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