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Drug to Biologic Transition: Is Purple The New Orange?

Approval Processes - The regulatory approval pathway for a new “biological product” submitted as a Biologics License Application (BLA) under the Biologics Price Competition and Innovation Act (BPCIA), is now separate from...more

What to Watch in 2021 - Big Changes for Drug Companies in China

For several years, China has been evaluating changes to its drug approval system to promote drug innovation and patient access to medicines. The year 2020 saw China begin taking steps towards adopting some of those changes....more

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