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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. We heard and felt the anxiety from many of our clients about the uncertainty this caused. After all, this is what incentives are for.