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
Approximately 550,000 Canadians suffer from the neurodegenerative disease known as Alzheimer’s Disease, which is also the cause of 60% to 70% of cases of dementia. This disease is associated with symptoms such as memory loss, difficulty performing simple tasks, disorientation of time and space, and even sudden changes in mood or personality. It is a
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
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
