Cato Research

Author's details

Name: Emily Haga
Date registered: August 15, 2017

Latest posts

  1. New FDA Guidances for June to August 2019 — September 9, 2019
  2. What’s New Health Canada? June and July 2019 Updates — August 26, 2019
  3. Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient — July 23, 2019
  4. New FDA Guidance’s For May 2019 — June 14, 2019
  5. New FDA Guidance’s for April 2019 — May 10, 2019

Author's posts listings

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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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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Feb 28 2019

Revised FDA Guidance on Developing Rare Disease Therapies

by Kristen Biernat, Ph.D., Scientist at Cato Research   Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose a significant health care concern.1 There are approximately 7,000 rare diseases that cumulatively affect more than 25 million Americans, half of which are children.2 In addition, most rare diseases are serious …

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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Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products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 11 2019

New FDA Guidances for January 2019

By Zachary Swan, Ph.D., RAC (US), Regulatory Scientist at Cato Research  FDA draft and final guidances released from CDER, CBER, and CDRH in January are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Rare Diseases: Common Issues in Drug Development Guidance for …

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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 29 2019

New Year New FDA Strategic Framework on Real World Evidence Program

By Dieanira Erudaitius, Ph.D., Postdoctoral Research Fellow at Cato Research   Overview Today there remains an ever-growing ability to generate, collect, and store vast amounts of health-related data. Availability of such data has opened the doors for the opportunity to leverage this information when developing drugs, for example in designing clinical trials. Having all this …

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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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Jan 17 2019

Stay on the Safe Side- Reference Safety Information – Europe

Vivienne Ben-David, B.Sc. (Pharmacy) PGDip. Project Manager & Associate Director, Pharmacovigilance ROW Cato Research   Aside from New Year’s resolutions and a clean sweep, what else should you refresh in 2019? I politely suggest your understanding of Reference Safety Information (RSI) in the EU. In Nov 2017, the Clinical Trials Facilitation Group published the Reference …

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