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Expediting The Expedited: How Rolling CMC Review Process Is Working For COVID-19 Vaccines

 
• By Bowman Cox

US, EU and Canadian authorities recently discussed their approaches to rolling reviews of CMC applications for coronavirus vaccines.

Timer
rolling toward approval • Source: Shutterstock

Rolling submissions of chemistry, manufacturing and controls information are playing a key role in accelerating regulatory reviews of COVID-19 vaccines and therapeutics to speeds never envisioned in the many acceleration initiatives of recent years.

A recent international regulatory panel discussion that pointed to several factors such as platform technologies and regulatory policies for pandemics that can play a role in safely rushing coronavirus vaccines...

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