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Value-Based Drug Pricing in Canada and its Limitations
Drug pricing is a complex and controversial issue that often sparks debates among patients, pharmaceutical companies, and the government. Prices can vary significantly...
Addressing Underrepresentation in Clinical Trials: FDA's Diversity Action Plan
The U.S. Food and Drug Administration (FDA) released a new draft guidance in June 2024 to enhance the diversity of clinical trial participants. The guidance details the...
VIRTUAL HEALTHCARE IN CANADA
“Virtual care” is defined as any “interaction between patients and/or members of their circle of care, occurring remotely, using any forms of communication or...
Artificial Intelligence – Revolutionizing the Healthcare Industry
What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....
3D Printing Our Way To Better Health Care
What is 3D Printing? 3-Dimensional (3D) printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is...
Digital Therapeutics - Reshaping the future of medicine
Digital Therapeutics – Reshaping the future of medicine What is Digital Therapeutics? With healthcare becoming digital, patients today are more empowered than ever before....
The Need for Regulatory Innovation in Canada: A Series (Issue 1)
The Need for Regulatory Innovation in Canada: A Series (Issue 1) Healthcare innovation has a strong position in Canada. From Insulin to Pacemaker to Polio Vaccine, medical...