Rare Pediatric Disease Priority Review Voucher definition

Rare Pediatric Disease Priority Review Voucher or “PRV” means a voucher issued by the United States Secretary of Health and Human Services to the sponsor of a rare pediatric disease product application at the time of a marketing application approval, which entitles the holder of the voucher to designate a single human drug application submitted under Section 505(b)(1) of the FD&C Act or Section 351(a) of the United States Public Health Service Act as qualifying for a priority review, as further defined in 21 U.S.C. 360ff or any subsequent or superseding statute conferring similar rights.
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Rare Pediatric Disease Priority Review Voucher or “PRV” means a voucher issued by the United States Secretary of Health and Human Services to the sponsor of a rare pediatric disease product application at the time of a marketing application approval, which entitles the holder of the voucher to designate a single human drug application submitted under Section 505(b)(1) of the FD&C Act or Section 351(a) of the Unitied States Public Health Service Act as qualifying for a priority review, as further defined in 21 U.S.C. 360ff or any subsequent or superseding statute conferring similar rights.
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Rare Pediatric Disease Priority Review Voucher means a priority review voucher issued by the FDA or otherwise under the authority of the United States Department of Health and Human Services to Fibrocell (or its Affiliate(s)) as the sponsor of a rare pediatric disease product application related to the Product, that entitles the holder of such voucher to priority review of a single human drug application submitted under Section 505(b)(1) or 505(b)(2) of the FDCA or Section 351(a) of the United States Public Health Service Act, as further defined in the FDCA, or any successor or similar voucher under any successor statute. 1.91 “RDEB” has the meaning set forth in the recitals hereto. 1.92 “Regulatory Approval” means, with respect to the Product, approval by the FDA of a BLA or other applicable filing and satisfaction of related applicable FDA registration and notification requirements with respect to the Product. 1.93 “Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities, including the FDA, regulating or otherwise exercising authority with respect to the Exploitation of the Product in the Territory. 1.94 “Regulatory Plan” has the meaning set forth in Section 5.2. 1.95 “Representing Party” has the meaning set forth in Section 13.1. 1.96 “Sublicense” means any agreement entered into by CCP and any person or entity, including Affiliates of CCP, granting such person or entity rights under any Fibrocell Patent Rights or Fibrocell Know-How, as the case may be, including grants of covenants not to xxx and options to obtain licenses and/or sublicenses. 1.97 “Sublicensee” means any person or entity, including Affiliates of CCP, to which CCP grants a Sublicense under this Agreement. 1.98 “Territory” means the United States of America and its territories, commonwealths and protectorates (including Puerto Rico and Guam). 1.99 “Third Party” means any person or entity other than CCP, Fibrocell, or an Affiliate of either of them. 1.100 “Trademark” means any word, name, symbol, color, designation or device or any combination thereof, whether registered or unregistered, including any trademark, trade dress, service xxxx, service name, brand xxxx, trade name, brand name, logo or business symbol. 1.101 “Valid Claim” means, for a country, a claim of an unexpired issued Patent or a pending Patent Application filed and kept pending in good faith, where either or both (a) ...
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Examples of Rare Pediatric Disease Priority Review Voucher in a sentence

  • With passage of the 21st Century Cures Act in December 2016, the Rare Pediatric Disease Priority Review Voucher program was reauthorized until 2020.

  • Reauthorization of Rare Pediatric Disease Priority Review Voucher Incentive Program BackgroundThe Food and Drug Administration Safety and Innovation Act (P.L. 112-144) added FFDCA Section 529 to create a new program, funded by user fees, to provide a transferable voucher, under specified conditions, to a sponsor of an approved new drug or biological product for a rare pediatric disease to be used for the priority review of another application.

  • Additionally, the FDA’s Rare Pediatric Disease Priority Review Voucher Program states that a sponsor with a Rare Pediatric Disease designation who receives a New Drug Application (NDA) or Biologic License Application (BLA) approval for a rare pediatric disease may be eligible for a voucher that can be redeemed to obtain priority review for any subsequent marketing application.

  • H.R. 6, Section 2152, Reauthorization of Rare Pediatric Disease Priority Review Voucher Incentive Program, also contained a comparable provision.

  • Comparable Provisions in the 21st Century Cures ActH.R. 6 contains a comparable provision (Section 2152, Reauthorization of Rare Pediatric Disease Priority Review Voucher Incentive Program), which would extend the authority to award rare pediatric disease priority review vouchers until December 31, 2018.

  • Re- authorizing the Rare Pediatric Disease Priority Review Voucher Program, however, is a crit- ical way of providing the necessary incentives to ensure children like Rafi, Jackson, and Mikey will soon benefit from this important re- search in the form of FDA-approved therapies.

  • The remaining US$350million, is to be paid on achievement of a series of 4 thresholds of total annual sales for all indications.– One third of the market value of any Rare Pediatric Disease Priority Review Voucher, if awarded to ACADIA by the US Food and Drug Administration upon approval of a New Drug Application for trofinetide.

  • Except as specifically set forth herein or therein, neither the Stockholder, the Company nor any Buyer makes any representation, warranty, covenant or undertaking with respect to such matters.

  • Epps, Assistant Counsel, Bureau of Regulatory Coun- sel, Office of Chief Counsel, Rachel Carson State Office Building, 9th Floor, P.

  • In addition to the numerous guidance documents under development as described above, FDA is planning to issue a draft guidance document on the Rare Pediatric Disease Priority Review Voucher Program.

Related to Rare Pediatric Disease Priority Review Voucher

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Urgent care request means a claim relating to an admission, availability of care, continued stay or health care service for which the covered person received emergency services but has not been discharged from a facility, or any Pre-Service Claim or concurrent care claim for medical care or treatment for which application of the time periods for making a regular external review determination:

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Disinfection profile means a summary of Giardia lamblia inactivation through the treatment plant.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Routine patient care costs means Covered Medical Expenses which are typically provided absent a clinical trial and not otherwise excluded under the Policy. Routine patient care costs do not include:

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Screening Test means a drug or alcohol test which uses a method of analysis allowed by the Minnesota Drug and Alcohol Testing in the Workplace Act to be used for such purposes.