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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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Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

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Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
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More from North America

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.