Cato Research

Author's details

Name: Emily Haga
Date registered: August 15, 2017

Latest posts

  1. Stay on the Safe Side- Reference Safety Information – Europe — January 17, 2019
  2. New FDA Guidances for December 2018 — January 4, 2019
  3. What’s New Health Canada? — December 27, 2018
  4. New FDA Guidances for November 2018 — December 11, 2018
  5. Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank — December 4, 2018

Author's posts listings

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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Jun 21

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     Health Canada New Guidance Documents (Drugs and Biologics)   Health Canada Guidance Type Date Posted Cancellation …

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Jun 13

2018 Changes in the User Fee Program for Prescription Drugs Under PDUFA VI

By Juliati Rahajeng, Ph.D., Scientist at Cato Research   The Food and Drug Administration Reauthorization Act (FDARA) was signed into law by the President on August 18, 2017. The law comprises the reauthorization of the Prescription Drug User Fee Act (PDUFA), which gives the Food and Drug Administration (FDA) the resources to sustain a predictable …

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Jun 08

New FDA Guidances for May 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 Development of a Shared System REMS Guidance for Industry – Draft …

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May 16

New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program

Our Regulatory Experts Can Help!

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist   The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018 to 2022, known as PDUFA VI, includes language to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as model-informed drug development …

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May 07

New FDA Guidances for April 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 Multiple Function Device Products: Policy and Considerations – Draft Guidance …

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Apr 25

Exception from Informed Consent in Emergency Research

by Reshma Jagasia, Ph.D., Scientist at Cato Research by Nicole Tackmann, Ph.D., Clinical Strategy Intern at Cato Research   All clinical investigations conducted in the United States are subject to informed consent regulations under federal law (21 CFR Part 50 Subpart B). These regulations define the responsibilities of a clinical investigator to describe to a …

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Apr 13

New FDA Guidances for February and March 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in February and March are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Chronic Obstructive Pulmonary Disease: Use of the St. …

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Mar 27

Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research   Submitting IND safety reports to an IND in eCTD format is slightly different when using us-regional DTD v3.3 versus v2.01. Keep in mind that the following aspects remain UNCHANGED for both versions: Each individual IND safety report should be provided in Section 5.3 of …

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