Priority Review Voucher definition

Priority Review Voucher means a priority review voucher issued by the United States Department of Health and Human Services that entitles the holder of such voucher to Priority Review of a single human drug application submitted under Section 505(b)(1) of the Act or Section 351(a) of the United States Public Health Service Act, as further defined in Section 529(a)(2) of the Act (21 U.S.C. § 360ff(a)(2)).

Priority Review Voucher means a voucher issued by the FDA to the sponsor of a rare pediatric disease product application, as such term is defined in 21 U.S.C. § 360ff, which entitles the holder of such voucher to priority review of an NDA after the date of approval of the rare pediatric disease product application.

Priority Review Voucher means a priority review voucher granted by the FDA solely with respect to any Product Candidate and not with respect to any other product candidate of the Warrant Holder.

Examples of Priority Review Voucher in a sentence

• Rare pediatric priority review voucher extension.Section 2105 extends the Rare Pediatric Priority Review Voucher (PRV) program at the Food and Drug Administration through December 11, 2020.

• Seller is the holder of all right, title and interest in and to the Priority Review Voucher (as defined below).

• Details on conducting this analysis can be found in 23 CFR 771.135.Section 4.1.7.4 provides guidance on the required documentation for Section 4(f) evaluations.

• To the Knowledge of Seller, there is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the Approval Letter.

• Buyer, its Affiliates, or any Buyer transferee of the Priority Review Voucher shall be solely responsible for the payment of the priority review fee described in 21 U.S.C. § 360ff(c) (the “Priority Review Fee”) and all other user fees applicable to the human drug application for which the Priority Review Voucher is redeemed, following the Closing.

More Definitions of Priority Review Voucher

Priority Review Voucher means a voucher issued by

Priority Review Voucher means the priority review voucher assigned tracking number PRV NDA 214662 issued by the Secretary of the Department of Health and Human Services pursuant to Section 529(b)(1) of the FFDCA to Seller, as evidenced by the Approval Letters, that entitles the holder to Priority Review of a single human drug application.

Priority Review Voucher or “PRV” means a priority review voucher issued by the United States Secretary of Health and Human Services to the sponsor of a rare pediatric disease product application or a qualifying tropical disease product application, that may be transferred and entitles the holder of such voucher to Priority Review of a single human drug application submitted under section 505(b)(1) or section 351(a) of the United States Public Health Service Act.

Priority Review Voucher means a voucher issued by the Secretary to the sponsor of a Rare Pediatric Disease Product Application that entitles the holder of such voucher to priority review of a single human drug application submitted under 21 USC § 355(b)(1) or Section 351(a) of the Public Health Service Act [42 USC § 262(a)] after the date of approval of the Rare Pediatric Disease Product Application.

Priority Review Voucher means the priority review voucher issued by the United States Secretary of Health and Human Services, Food and Drug Administration, to Seller, as evidenced in the Approval Letter, identified by priority review voucher number PRV BLA 125755/0.

Priority Review Voucher means a voucher issued by the Secretary to the Licensee for a rare pediatric disease product application that entitles Licensee or Licensee’s transferee of such voucher to Priority Review of a human drug application submitted under section 505(b)(1) [21 USC § 355(b)(1)] or section 351(a) of the Public Health Service Act [42 USC § 262] after the date of approval of the rare pediatric disease product application. For the purposes of this Agreement, Priority Review Voucher refers to any such voucher that the Licensee obtains as a result of its activities that relied upon Licensed Products or Licensed Processes.

Priority Review Voucher means the priority review voucher issued by the FDA to Seller with tracking number PRV NDA 208684, as the sponsor of a rare pediatric disease product application for Emflaza(tm) (deflazacort) (“Emflaza”), that entitles the holder of such voucher to Priority Review of a single human drug application submitted under Section 505(b)(l) of the FDA Act or a single biologic application submitted under Section 351 of the Public Health Service Act, as further defined in the FDA Act (21 U.S.C. 360ff).