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Canada Proposed Rules Prescription Drugs

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Issues Proposed Policies to Facilitate Importation of Prescription Drugs from Canada, Other Countries

• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more

Smart & Biggar

Health Canada and CADTH launch new initiative to provide early parallel scientific advice

Smart & Biggar on

On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer...more

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