Tag Archive: Cato Research

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 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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Mar 08

Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018

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By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic common technical document (eCTD) format. Section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act) authorizes the United States Food and Drug Administration (FDA) to …

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Mar 01

Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission for the Evaluation of Proprietary Names”, applicants must submit proposed proprietary names to the FDA for review as part of New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs).  …

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