Priority Review definition

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for “priority review” applications in the then-current Prescription Drug User Fee Act goals letter, as described in FDA Draft Guidance, “Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry” (July 2019).

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.

Examples of Priority Review in a sentence

• Within [***] days of Novartis’ receipt of the PRV Notice, Novartis may elect by written notice to Pharming to purchase the Priority Review Voucher (a “PRV Purchase”).

• CUTEC is a subcommittee (working group of non- elected public officials and staff) of CUUATS Technical Committee as other subcommittees (Project Priority Review, Long Range Transportation Plan, Intelligent Transportation System, Safety, etc.); therefore, it does not need to be listed in the CUUATS Intergovernmental Agreement.

• For clarity, examples of Commercial Benefits include the sales of a Project Vaccine at market prices, commercial licensing of Project IP, receipt of government-granted incentives such as Priority Review Vouchers and revenue from the commercialisation of combination, derivative or follow-on products (including antibody products, assays and vaccines) or application of production technology resulting in whole or part from CEPI funding.

• In January 2017, we announced that RHB‑204 had been granted QIDP designation by the FDA for the treatment of pulmonary NTM disease, including eligibility for Priority Review, Accelerated Approval and an extended market exclusivity period, if approved for marketing in the U.S. In October 2020, we announced that the FDA granted RHB-204 Orphan Drug designation which together with the QIDP designation will extend U.S. market exclusivity to a total of 12 years, if RHB- 204 is approved by the FDA.

• The FDA has granted this application Priority Review, a designation which is granted to applications for potential drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions when compared to standard applications.

More Definitions of Priority Review

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, 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 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 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 procedure: used for drugs that treat serious conditions and present major therapeutic advances or provide treatment for a disease in which there is no suitable therapy. This procedure means that the time it takes the FDA to review an application is reduced to six months (instead of 10). Priority Review corresponds to the so-called “Accelerated Assessment” in Europe.

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.

Priority Review means a priority review of and action by the FDA upon a human drug application, which is submitted under Section 505(b)(1) of the FDCA or under Section 351 of the PHSA, by the FDA not later than six (6) months after the receipt of such application by the FDA, as defined in Section 524(a)(1) of the FDCA as interpreted by the FDA Guidance For Industry, Tropical Disease Priority Review Vouchers, Oct. 2016 (“Tropical Disease Guidance”), Page 4, Question 7.