FDA Guidelines for Conducting Clinical Trials During COVID-19 Pandemic

The Food and Drug Administration (FDA) of the United States of America has recently issued a statement, updating Research Sites, Investigators, and IRBs on how best to deal with the ongoing challenges posed by COVID-19. These guidelines will help ensure the safety of trial participants, compliance with good clinical practice (GCP), and minimizing risks to

Update on Health Canada and FDA Collaboration

Last summer, we reported that Health Canada and the FDA were beginning a series of meetings to discuss how Canada and the U.S. could work together to make their drug approval processes more efficient. At that time, they announced the formation of a council (it’s called the Canada-US Regulatory Cooperation Council, or RCC) to look

Can Health Canada and the FDA work together to streamline the drug approval process?

Health Canada (HC) and the Food and Drug Administration (FDA) are meeting for the first time on May 15th, 2015 to begin discussions on how the United States and Canada can make their drug approval processes more efficient. With Prime Minister Stephen Harper’s and President Barack Obama’s backing, the two agencies have formed a council