Category 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 …

Continue reading »

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 …

Continue reading »

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 …

Continue reading »

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   Special Interest Guidances/Information Date Posted Multiple Function Device Products: Policy and Considerations – Draft Guidance …

Continue reading »

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. …

Continue reading »

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).  …

Continue reading »

Feb 20

New FDA Guidances for January 2018

By Sheila Plant, PhD, MHS, RAC (US), Assistant Director, Regulatory Strategy, US, Cato Research   FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted.  CDRH has also released an “A-list” and a “B-list” of proposed guidances for fiscal year 2018 and is seeking feedback on the relative priority …

Continue reading »

Feb 15

What’s New Health Canada?

By Sandra Salem, Ph.D., Regulatory Scientist   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, Biologics, Medical Devices and Natural & Non-prescription Health Products)   Health Canada Guidance Type …

Continue reading »

Jan 22

Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products

By: Robert McNeill, Ph.D., Scientist at Cato Research In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products (Version date: 18 December 2017) (2017 PDUFA Meetings draft guidance). At the same time, two guidance documents were …

Continue reading »

Jan 17

South Africa is Transitioning to a New Regulator of Medicines and Medical Devices

By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World Cato Research, South Africa   On 01 June 2017, the President of South Africa proclaimed revisions to the Medicines Act. These provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new …

Continue reading »

Older posts «

» Newer posts