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Health Canada Risk Management

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

Morris James LLP on

Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Husch Blackwell LLP

Clinical Trial Audit Readiness: A Step-by-Step Guide for Research Sites

Husch Blackwell LLP on

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more

Smart & Biggar

Health Canada publishes guidance on submitting risk management plans

Smart & Biggar on

As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more

Smart & Biggar

Health Canada publishes guidance on distinction between advertising and other activities for health products

Smart & Biggar on

Promotional messages and activities regarding a health product are subject to the advertising provisions under the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act and/or their associated regulations. For...more

Smart & Biggar

Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices

Smart & Biggar on

UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more

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