Complex Generics: US FDA, Sponsors View Roadblocks Very Differently
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.
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While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.
Will the growing workload cause GDUFA fees to increase or prompt other changes?
Strides files for a biosimilar to Eli Lilly’s Forteo (teriparatide) in the EU, marking the beginning of its journey in the biosimilars segment. Meanwhile, it hopes to enter a manufacturing tie-up with COVID-19 vaccine players in H2 while also planning a launch of favipiravir in markets outside India.