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New Canadian Rule Allows Rolling Data Submissions For COVID-19 Drugs, Vaccines

Enabling Timely Access To Novel Products Is Key Focus

 
• By Vibha Sharma

The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.

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Health Canada is prioritizing the review of all COVID-19 drug applications • Source: Shutterstock

The Canadian government has introduced new temporary mechanisms to speed up the approval of drugs and vaccines for COVID-19. It is also allowing certain “promising” unapproved drugs and vaccines to be stocked up in Canadian facilities to enable their quick distribution following authorization.

The changes, introduced through an interim order signed on 16 September, provide for three alternative mechanisms to expedite...

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• By Neena Brizmohun

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More from North America

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• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

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• By Sue Sutter

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

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