Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.
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The FDA has opened a portal of inquiry that will be answered by Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, on r/medicine at Reddit. There had never been an opportunity like this to hear directly from the agency and in writing. Recently, Yim had answered the following questions [sic]:
Yim answered all these questions and brought much more knowledge, so I recommend stakeholders take this opportunity to ask questions. However, so few questions fail to benefit from this portal. I am encouraging all stakeholders to clear their misconceptions and also encourage the FDA to modify the Biologics Price Competition and Innovation Act guidelines to expedite the approval of biosimilars.I just asked this question:
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