IND Application definition

IND Application means investigational new drug application filed with the U.S. Food and Drug Administration or any successor application thereto and any foreign equivalent of any such application filed with the applicable regulatory authority.
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IND Application has the meaning provided in Section 9.2.1.
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IND Application means an application submitted to a Competent Authority for authorization by the applicable Competent Authority to initiate human clinical trials, including an (i) Investigational New Drug application filed with the US Food and Drug Administration in the United States, (ii) a clinical trial application submitted to the European Medicines Agency of the European Union, (iii) a clinical trial application submitted to the National Medical Products Administration (NMPA) of China, and (iv) any equivalent filing in any other jurisdiction.
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Examples of IND Application in a sentence

  • Studies conducted in the United States or under a U.S. Investigational New Drug (IND) Application will comply with U.S. FDA regulations and applicable local, state, and federal laws.

  • The IND Application will be in material compliance with applicable laws and rules and regulations when filed.

  • Following submission of a new IND application either comprising of: (“New IND Application”) Telix shall make a one-time payment to Wilex of US$[**] within [**] after receiving approval or of a corresponding confirmation by the FDA (or equivalent regulatory body) of the New IND Application.

  • Following submission of a new IND application [**] (“New IND Application”), Telix shall make a one-time payment to Wilex of US$[**] within [**] after receiving approval by the FDA (or equivalent regulatory body) of the New IND Application.

  • Approved Investigator will submit an IND Application to the FDA to conduct the Formulary Protocol in accordance with obligations of 21 CFR Part 312, and will be responsible for all regulatory submissions to the FDA concerning the Formulary Protocol.

  • Refer to HRPP OM Part 6.II.B.2Refer to IRBMED Guidance – Investigational Device Exemption (IDE) Application and Investigational New Drug (IND) Application.

  • The increase is related to expenses incurred for the research and development of PEA, for Phase 1 and 2 Safety and Tolerability testing, FDA IND Application and COVID-19 study.For the three months ended December 31, 2020, share-based payments expense was $215,255 compared to $2,885,792 for the three months ended December 31, 2019.

  • DsRNA helices typically adopt an A-form structure (A- RNA), however, A-RNA can transition into a different conformation called Z-RNA.

  • AGIX, its Affiliate or a third party selected by AGIX will be solely responsible for the selection and testing of Licensed Products that it schedules to advance into IND Application in the U.S., or equivalent development programs throughout the world.

  • This phase lasts about 7-8 years, and only one in one thousand compounds make it to the next phase.• Investigational New Drug (IND) Application: Having decided during the pre-clinical testing which compounds seem to have the best biologic activity against a disease, as well as the least side-effects, the pharmaceutical company files an IND application with the U.S. Food and Drug Administration (FDA) to begin to test the drug on humans.


More Definitions of IND Application

IND Application means an application for approval of a request for authorization by the U.S. Food and Drug Administration or similar authority in the jurisdiction to administer an IND to humans.
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IND Application means an Investigational New Drug Application filed with the United States Food & Drug Administration prior to administration of a pharmaceutical product to humans.
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IND Application or “IND” means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, including any amendments or supplements thereto, or (b) the equivalent application to a Regulatory Authority in any other regulatory jurisdiction, which must be in effect to initiate or conduct clinical testing of a pharmaceutical or biological product in humans in such jurisdiction, including any amendments or supplements thereto.
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Related to IND Application

  • Land application means the spraying or spreading of sewage sludge onto the land surface, the injection of sewage sludge below the land surface, or the incorporation of sewage sludge into the soil for the purposes of conditioning the soil or fertilizing crops or vegetation grown in the soil.

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • 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.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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.

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

  • Biosimilar Application has the meaning set forth in Section 7.3.3.

  • Client Application means an application developed by Licensee that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • 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.

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

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

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

  • 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;

  • Access Application means an application for Access Rights as described in section 3.7;

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Completed application means an application that satisfies all of the information and other requirements of the Tariff, including any required deposit.

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Creation Application means an application by a Participating Dealer for the creation and issue of Units in an Application Unit size (or whole multiples thereof) in accordance with the Operating Guidelines and the Trust Deed.

  • Database application form means the application form required by the Hibiscus Coast Municipality to be filled in by the successful tenderer, following the award of the contract, for inclusion on the HCM database before payment is made.

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

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • Transfer Application means an application and agreement for transfer of Units in the form set forth on the back of a Certificate or in a form substantially to the same effect in a separate instrument.

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.