Cato Research

Author's details

Name: Emily Haga
Date registered: August 15, 2017

Latest posts

  1. New FDA Guidance’s for April 2019 — May 10, 2019
  2. New FDA Guidance on Natural History Studies for Rare Diseases — April 24, 2019
  3. 2019 March FDA Guidances — April 10, 2019
  4. Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry? — March 22, 2019
  5. FDA Approval of New Opioid Drug (DSUVIATM) Stirs Controversy – Is it Necessary or Not? — March 20, 2019

Author's posts listings

Feb 15

Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products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Ph.D., Clinical Strategy Scientist at Cato Research, and Dieanira Erudaitius, Ph.D., Scientist at Cato Research   A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable products regulated under the Biosimilar User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

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

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

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

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

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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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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