Approval Pathway definition

Approval Pathway shall have the meaning provided in Section 5.2(d)(iv).
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Examples of Approval Pathway in a sentence

  • Future approvals are made in accordance with the Approval Pathway and Approval Route outlined in this report.

  • Future approvals are made in accordance with the Approval Pathway and Approval Route outlined in this report including at decision points 4 and 5 through a delegation to the Combined Authority’s Managing Director following a recommendation by the Combined Authority’s Programme Appraisal Team.

  • That the Approval Pathway be amended so that scheme returns to PAT, Investment Committee and Combined Authority at Decision Point 3 to request further development costs and land acquisition costs.

  • Kalwall 2-3/4” Panel, exterior color to be Crystal, interior color to be White, visible light transmission to be 26%.3.

  • Strengthening the Accelerated Approval Pathway: An Analysis of Potential Policy Reforms and Their Impact on Uncertainty, Access, Innovation, and Costs.

  • DaColP,CattinL,FondaM,MameliM,FeruglioF.Pantethineinthetreatmentofhypercholesterolemia:arandomizeddouble-blindtrialversustiadenol.

  • That the Approval Pathway be amended so that the scheme returns to the PAT, Investment Committee and Combined Authority at Decision Point 3 to request further development costs and land acquisition costs.

  • The company must submit the initial Pediatric Study Plan to FDA within 60 calendar days of completing the EOP2 meeting, or the EOP1 meeting if the product is developed using the Accelerated Approval Pathway.

  • Approval Pathway for Biosimilar Biological ProductsThis section would amend PHSA Sec.

  • CONFIDENTIAL TREATMENT REQUESTED determined and reconciled as if such Approved Licensed Product had only Achieved milestones within such Approval Pathway and for the Approved Indication (taking into account all other milestones that have been Achieved with respect to the applicable Arcus Program as of the date of such Marketing Approval).

Related to Approval Pathway

  • Pathway means a transport mechanism by which chemicals of concern may reach a receptor(s) or the location(s) of a potential receptor.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Development approval means any written authorization from a

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Career Pathways means a sub-grouping used as an organizing tool for curriculum design and instruction of occupations and career specialities that share a set of common knowledge and skills for career success;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Assisted amusement device means an amusement device, skill device, or ride

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Improvement completion assurance means a surety bond, letter of credit,

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including: