Government of Canada Passes “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) – Modernized Patient Safety Laws for Drugs and Medical Devices

On December 6, 2013 it was announced that a new patient safety legislation would be introduced known as the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)”. The law is named after Vanessa Young, the daughter of MP Terence Young, who died of a heart attack after taking an unsafe prescription drug…[Read our Original Blog Post Regarding the Announcement of Vanessa’s Law Here]
Since the announcement in 2013 the law has passed and marks a major milestone in Canada’s drug safety history. This Act will Continue reading

The FDA Releases New Guidance Document to Strengthen Cybersecurity of Medical Devices

14.11.13The US FDA has released a final guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices to strengthen the safety of medical devices.

Although medical devices have the ability to improve patient care and create efficiencies in the healthcare system as they become more interconnected and interoperable, risks for Continue reading

Expedited Access for Premarket Approval (EAP) Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance

FDA Draft Guidance: Expedited Access for Premarket Approval (EAP) Medical Devices On April 23, 2014 the FDA released for comment purposes only, the Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry. Comments should be received by the FDA within 90 days of publication in the Federal Register.

The Expedited Access for Premarket Approval (EAP) is a new “voluntary program for Continue reading