BIO Submits Comments on Rare Pediatric Disease Priority Review Vouchers
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry entitled “Rare Pediatric Disease Priority Review Vouchers.”</p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry entitled “Rare Pediatric Disease Priority Review Vouchers.”
BIO appreciates FDA’s implementation of the rare pediatric disease priority review voucher (PRV) in a manner that stimulates new drug development of new therapies for devastating childhood diseases and serious conditions through additional incentive mechanisms. On the whole, we believe that the Draft Guidance is well written, clear, and will clarify the process of seeking the rare pediatric disease designation and rare pediatric disease priority review vouchers.
