Tropical disease PRV fix didn’t stop Novartis from winning another
Back in 2017, a new law was enacted, known as the FDA Reauthorization Act (FDARA), which contained not only the new user fee programs for pharmaceuticals, medical devices, generics and biosimilars, but also a slight tweak to the tropical disease priority review voucher (PRV) program.
The change was meant to ensure that companies winning PRVs actually performed some of the clinical work to bring the tropical disease drug to market in the US, and that the drugs “were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme.”
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