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 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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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.

  • Investigational New Drug (IND) Application: is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans.

  • Preparation and Maintenance of the IND Application in eCTD Format By William K.

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

  • 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.

  • The requirements for mandatory IND Application Safety Reporting are the same as for all other IND applications.

  • The Team Leader/Team member, or their institution, shall submit and hold the Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE) for studies that are not deemed exempt.

  • The procedures for safety, annual, and other IND Application Reporting for expanded access applications are like those for investigational IND applications.

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

  • In addition to the requirements above, the UCI Investigator must submit a copy of the FDA Notice of Claimed Investigational Exemption for a New Drug (IND Application) along with their IRB protocol application for review.


More Definitions of IND Application

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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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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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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Related to IND Application

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

  • 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.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.