Investigational Application definition

Investigational Application means an authorization to commence human clinical studies or distribute an investigational product, including (a) an investigational device exemption (IDE), (b) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (c) any equivalent of a United States IDE in other countries or regulatory jurisdictions, (d) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing and (e) all related documents and correspondence thereto, including documents and correspondence with Institutional Review Boards (IRBs).
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Investigational Application means an authorization to commence human clinical studies or distribute an investigational product, including (a) an investigational device exemption as set forth in 21 C.F.R. § 812 (“IDE”), (b) any equivalent of a IDE in other countries or regulatory jurisdictions, (c) any approvals required from applicable Institutional Review Boards for the conduct of such human clinical studies and (d) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
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Investigational Application means an application, including an application filed with a Regulatory Agency, for authorization to commence human clinical studies or distribute an investigational product, including (a) an IND, (b) an IDE, (c) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (d) any equivalent of a United States IND or IDE in other countries or regulatory jurisdictions, (e) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing and (f) all related documents and correspondence thereto, including documents and correspondence with Institutional Review Boards (IRBs).
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Examples of Investigational Application in a sentence

  • To the extent necessary by applicable Law, the Borrower or its applicable Subsidiary has obtained all necessary Regulatory Authorizations, including an Investigational Application, material to the conduct of any clinical investigations conducted by or on behalf of the Borrower or such Subsidiary.

  • Firstly, research focuses on duration, industry composition and residential status, medium of communication, application of EVA metrics and the firm specific attributes that are associated with companies’ choice of EVA disclosure.

  • To the extent necessary by applicable Law, the Borrower or its applicable Subsidiary has obtained all necessary and material Regulatory Authorizations, including an Investigational Application for the conduct of any clinical investigations conducted by or on behalf of the Borrower or such Subsidiary.

  • The Client agrees that he shall be the only authorized user of the Web Facility.


More Definitions of Investigational Application

Investigational Application means an application, including an application filed with a Regulatory Agency, for authorization to commence human clinical studies or distribute an investigational product, including (a) an Investigational Device Exemption (“IDE”) as defined in the FD&C Act or any successor application or procedure filed with the FDA, (c) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (d) any equivalent of a United States IDE in other countries or regulatory jurisdictions, and (e) all amendments, extensions and renewals thereof that may be filed with respect to the foregoing.
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Investigational Application means an application, including an application filed with a Regulatory Agency, for authorization to commence human clinical studies or distribute an investigational product, including (a) an Investigational Drug Application (“IND”) as defined in the FD&C Act or any successor application or procedure filed with the FDA, (b) an Investigational Device Exemption (“IDE”) as defined in the FD&C Act or any successor application or procedure filed with the FDA, (c) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (d) any equivalent of a United States IND or IDE in other countries or regulatory jurisdictions, (e) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing and (f) all related documents and correspondence thereto, including documents and correspondence with Institutional Review Boards (IRBs).
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Investigational Application means an authorization to commence human clinical studies or distribute an investigational product, including (a) an IDE, (b) any equivalent of an IDE in other countries or regulatory jurisdictions, (c) any approvals required from applicable Institutional Review Boards for the conduct of such human clinical studies and (d) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing. “Investment” means, relative to any Person, (i) any loan, advance or extension of credit made by such Person to any other Person, including the purchase by such Person of any bonds, notes, debentures or other debt securities of any other Person, (ii) Contingent Liabilities in favor of any other Person, (iii) any Capital Securities held by such Person in any other Person and (iv) any Acquisition. The amount of any Investment shall be the original principal or capital amount thereof less all returns of principal or equity thereon and shall, if made by the transfer or exchange of property other than cash, be deemed to have been made in an original principal or capital amount equal to the fair market value of such property at the time of such Investment. “IT Assets” means the computers and other information technology infrastructure and assets used by the Borrower or any of the Subsidiaries in the conduct of their business as currently operated. “knowledge” means actual knowledge of any Authorized Officer of the Borrower or any Subsidiary or facts and circumstances that an Authorized Officer of the Borrower or any Subsidiary would reasonably be expected to be aware of as a result of the performance of such Authorized Officer’s regular duties with the Borrower or such Subsidiary. “Laws” means any U.S. or non-U.S. federal, state, provincial, territorial, municipal or local statute, treaty, rule, guideline, regulation, ordinance, code, administrative or judicial precedent or authority, including applicable Healthcare Laws or Privacy Laws, or (solely with respect to Patents) arising under an international convention, including any interpretation or administration thereof by any Governmental Authority or (solely with respect to Patents) international body charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests, licenses, authorizations and permits of, and agreements with, any Governmental Authority or (solely with respect to Patents) international body, in ...
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Related to Investigational Application

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • international application means an application filed under this Treaty;

  • investigating authority means an authority that in terms of national legislation may investigate unlawful activities;

  • 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.

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

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • 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.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith;

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • 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.

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

  • Product Complaint means any oral, electronic or written communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. A complaint may allege that an Adverse Event or Medical Device Malfunction (as defined herein) has occurred.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Regulatory Proceeding means a request for information, civil investigative demand, or civil proceeding commenced by service of a complaint or similar proceeding brought by or on behalf of the Federal Trade Commission, Federal Communications Commission, or any federal, state, local or foreign governmental entity in such entity’s regulatory or official capacity in connection with such proceeding.

  • Environmental Complaint shall have the meaning set forth in Section 4.19(d) hereof.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • Application Process means the online application process under which the Applicant applies for Hospitality Packages on the Webshop.

  • Commercial applicator means a person who, by contract or for hire, engages in the