Priority Review means a priority review of and action upon a human drug application, which is submitted under Section 505(b)(1) or 505(b)(2) of the FFDCA or under Section 351 of the Public Health Service Act, by the FDA not later than six (6) months after the receipt of such application by the FDA, as defined in Section 529(a)(1) of the FFDCA.
Priority Review means a priority review of and action upon a human drug application by the FDA not later than six (6) months after the filing of such application to the FDA, as defined in the FDA Act (21 U.S.C. 360ff).
Priority Review means review and action on a human drug application by the FDA in accordance with the timelines set forth by the FDA for “priority review” applications in the then-current Prescription Drug User Fee Act goals letter, as described in FDA Draft Guidance, “Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry” (July 2019).
Examples of Priority Review in a sentence
Similarly, Engel elasticity exceeds unity (is less than one) if expenditures on a good grow more than growth in income (grow less than growth in income).
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).
Priority Review, http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm.
Zogenix Announces U.S. FDA Acceptance for Priority Review of Supplemental New Drug Application for FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS).
More Definitions of Priority Review
Priority Review means review and action by the FDA on a human drug application in accordance with Section 529(a)(1) of the FDC Act.
Priority Review means, with respect to the Product NDA, a designation assigned by the FDA pursuant to which the time it takes the FDA to review a NDA is reduced.
Priority Review means a design review service for an APP Type 4 permit application that the Department completes using not more than 50 percent of the total review time-frame for the applicable Type 4 permit application as specified in 18 A.A.C. 1, Table 10.
Priority Review means, with respect to a human drug application as defined in section 735(1) [21 USC § 379g(1)], review and action by the Secretary of HHS (“Secretary”) on such application not later than six (6) months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the FDA and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.
Priority Review means a priority review of and action upon a human drug application by the FDA in accordance with a six (6) month timeframe, as defined in the FDCA (21 U.S.C. 360ff(a)(1)).
Priority Review means a priority review of and action upon a human drug application by the FDA in accordance with the timelines described in 21 U.S.C. 360bbb-4a(a)(2).
Priority Review means a review of a DAA by the applicable Regulatory Authority not later than six (6) months after the filing of DAA to such Regulatory Authority.