Category Archive: Medical 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 »

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 »

Jan 05

New FDA Guidances for December 2017

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 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Labeling for Combined Hormonal Contraceptives – Draft Guidance …

Continue reading »

Dec 20

New FDA Guidances for October and November 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in October and November 2017 are posted. Currently, there are no upcoming advisory committee meetings. Special Interest Guidances/Information Date Posted Select …

Continue reading »

Oct 18

What’s New Health Canada?

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate II   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 Publication of the Guidance Document: Certificate of …

Continue reading »

Sep 25

Time to Approval and the Metrics of Facilitated Regulatory Pathways

By Dr. Jack Snyder, RAC (US, EU, CA, GS), Asst. Managing Director and Clinical Research Physician at Cato Research “Early access pathways” for biomedical product marketing approval have attracted substantial attention recently, as Sarepta Therapeutics’ drug Exondys (eteplirsen) gained accelerated approval based on clinical data from just 12 patients.  In the United States, four “expedited” …

Continue reading »

Jul 10

New FDA Guidances for June 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in June 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special …

Continue reading »

Jun 05

New FDA Guidances for May 2017

By Sheila Plant, Ph.D., R.A.C., Assistant Director, Regulatory Strategy, US at Cato Research One revised draft FDA guidance, released from CBER, and two MAPPs, released from CDER, in May 2017, are posted.  In addition, upcoming advisory committee meetings to be held in June and July are listed below with links to more information. Special Interest …

Continue reading »

Mar 23

CANCER IMMUNOTHERAPY: A NEW HOPE

By Reshma Jagasia, Ph.D, Scientist at Cato Research The current standard of care for cancer treatment is surgery, chemotherapy, and radiation therapy – a standard that has persisted for decades. These treatments are invasive and not specific, killing healthy cells and tissues along with tumors. In the past decade, more targeted therapies have emerged, including …

Continue reading »

Mar 06

New FDA Guidances for February 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Q11 Development and Manufacture of Drug Substances—Questions and Answers …

Continue reading »

Older posts «