Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
Proteinqure Inc. has received regulatory clearances from the U.FDA and Health Canada to initiate a phase I trial of lead candidate, PQ-203. The trial will begin in Canada and expand to U.S. sites later in 2025. The FDA also granted PQ-203 fast track designation for triple-negative breast cancer (TNBC).
The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.
Fifty years after the term brain-computer interface (BCI) was coined, Neuralink and several other companies are reviving the promise of BCI for health care, as artificial intelligence and novel methods of neural signal detection work hand-in-hand to propel biomedical innovation.
Organox Ltd. gained approval from Health Canada for its Metra system for use during liver transplantation. The system utilizes normothermic machine perfusion to maintain donor livers under physiologic conditions prior to transplantation.
Palisade Bio Inc. has submitted a clinical trial application (CTA) for PALI-2108 for the treatment of ulcerative colitis, following a pre-CTA consultation meeting with Health Canada. Pending clearance, the company anticipates initiating a phase I study by year-end.
For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.
The U.S. FDA’s Jan. 5 approval of Florida’s plan to import prescription drugs from Canada to take advantage of their lower price triggered ongoing communication between senior U.S. officials and Canada’s Ministry of Health over Canadian concerns about maintaining sufficient drug supplies.
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