Tag Archive: drug development

Dec 22

What’s New Health Canada?

By Amelie Rodrigue-Way, PhD, 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 Quality (Chemistry and Manufacturing): New Drug …

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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 …

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Dec 07

Toward Compliance 2.0 : When your Pill is Connected to your Smartphone

By: David Hamel, Fellow Scientist Cato Research Canada The FDA approval of Abilify MyCite (aripiprazole tablets with sensor; by Otsuka) on 13 November 2017 for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults could mark a …

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Jul 14

FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS (ICH E14 (R3)) in 2005. This month, FDA published the most recent ICH updated list of questions and answers (ICH …

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Jun 19

What’s New Health Canada? April – May 2017

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 Guidance …

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Jun 19

What's New Health Canada? April – May 2017

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 Guidance …

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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 …

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Oct 20

Precision Medicine and the FDA

by Reshma Jagasia, Ph.D., Scientist at Cato Research “Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type — that was an important discovery. What if matching a cancer cure to our …

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Oct 12

New FDA Guidances for September 2016

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in September 2016, are posted. In addition, upcoming advisory committee meetings to be held in the next month are listed below with links to more information.   Special Interest Guidances/Information Date Posted Q7 …

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Sep 21

The Current Implementation of the Drug Supply Chain Security Act (DSCSA) Implementation Plan and Rare Disease Drugs

What is the Drug Supply Chain Security Act (DSCSA)? In November 2013 the Drug Quality and Security Act (DQSA) was signed into law with the intent to decrease incidence of counterfeit, falsified, or substandard prescription medication.  Title II of this act was the Drug Supply Chain Security Act (DSCSA), which lays the ten-year framework for …

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