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47500 records

Thousands of Canadians are turning to laser eye surgery to correct their vision and eliminate their dependency on glasses or …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Laser eye surgery correct vision eliminate dependency-on glasses contact lenses medical procedures benefits poses risks

Acetaminophen is safe and effective when used as directed, but there is a limit to how much you can take …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: acetaminophen safe and effective used as directed a limit how-much you can-take the recommended dose severe liver damage fatal liver damage

Educational module includes an outline of Vanessa’s Law, who/what/when of regulations for mandatory reporting of adverse drug reactions and medical …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 1 overview Vanessa’s Law reporting requirements mandatory reporting Adverse Drug Reactions Medical Device Incidents Hospitals

Educational module includes considerations for mandatory reporting of adverse drug reactions and medical device incidents, reporting options to Health Canada, …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 2 reporting processes mandatory reporting educational module adverse drug reactions medical device incidents reporting options reactions incidents problems

Educational module helps identify and overcome barriers to hospital mandatory reporting of adverse drug reactions and medical device incidents, recognize …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 3 Strategies mandatory reporting educational module barriers hospital mandatory reporting adverse drug reactions medical device incidents

Educational module provides overview of health product vigilance, report management, post-market surveillance activities and Health Canada risk communications.

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 4 safety findings Educational module health product vigilance report management post-market surveillance Health-Canada risk communications.

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Notice of clarification drug manufacturers sponsors Risk Management Plans controlled distribution programs Canadian Reference Products generic drug conducting comparative testing

We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Notice of clarification drug manufacturers sponsors Canadian-specific considerations risk management plans certain drug products

Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions.

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: optimizing use of Real-World-Evidence leveraging Real-World-Evidence inform Regulatory Decision-Making Drug Regulatory Decisions

This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, …

Record Modified: Apr 4, 2024
Record Released: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Overview guidance-document reporting adverse reactions Marketed Health Products Industry market authorization holders