In the November 17, 2015, Federal Register, FDA issued a priority review voucher to the sponsor of a rare pediatric disease product application for Strensiq (asfotase alfa), manufactured by Alexion Pharmaceuticals, Inc. FDA determined the application satisfied certain criteria to merit a priority review voucher pursuant to the Food and Drug Administration Safety and Innovation Act. The rare pediatric disease priority review voucher program is in its sunset period, which was triggered on March 17, 2015, with FDA's issuance of a third voucher under the program. Unless reauthorized by Congress, FDA may not issue pediatric vouchers after the one-year period following award of the third voucher.
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