Investigational New Drug Application definition

Investigational New Drug Application or “IND” means a filing in accordance with 21 C.F.R. Part 312 under which clinical investigation of an experimental drug or biologic (Investigational Agent) is performed in human subjects in the United States or intended to support a United States licensing action. The sponsor for the IND under this Agreement is the Institution or Approved Investigator.

Investigational New Drug Application means an investigational new drug application described in 21 CFR §312.23, obtained for purposes of conducting Clinical Trials in accordance with the requirements of the Act and the regulations promulgated thereunder, or the similar or equivalent application or approval under applicable Laws in another country, including all supplements and amendments thereto relating to the use of the Compound or Licensed Product.

Investigational New Drug Application means an Investigational New Drug Application filed with the FDA in the United States or any equivalent counterpart in any country other than the United States, including all supplements and amendments thereto.

Examples of Investigational New Drug Application in a sentence

• A body or institution which otherwise acts in a judicial capacity does not in principle cease to do so simply because of the passage of time.

• To the extent required by applicable laws and regulations of the FDA, the Company or the applicable Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

• If President determines that a requested change in scope would materially affect the purpose for which the award was made or the expected outcome (e.g., a project that now requires the filing of a new Investigational New Drug Application), the President may deny the request, terminate the award and provide up to 120 days of funding for wind down activities, and invite the Awardee to submit a new application, subject to GWG review and approval by Application Review Subcommittee.

• Biohaven will begin optimization of its formulation in 2016.Overall clinical development strategy: • On July 22, 2015, Biohaven Filed Investigational New Drug Application (IND) for BVH-0223 with United States Food and Drug Administration (FDA).

• In order to commence clinical trials of new products and certain new therapeutic uses of Hextend, it will be necessary for the Company to prepare and file with the FDA an Investigational New Drug Application ("IND") or an amendment to expand the present IND for Hextend.

More Definitions of Investigational New Drug Application

Investigational New Drug Application or “IND” means a filing in accordance with 21 C.F.R. Part 312.

Investigational New Drug Application means an application for required approvals or authorizations from the FDA to commence human clinical testing of a drug, as defined by the FDA, or the equivalent application in any other country.

Investigational New Drug Application means an application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder to the United States Food and Drug Administration (the "FDA"), or the equivalent application to the equivalent agency in jurisdictions outside the United States, the filing of which is necessary to commence clinical testing of Licensed Products in humans.

Investigational New Drug Application. (IND) is filed in accordance with 21 C.F.R. Part 312 under which clinical investigation of a Test Article (an experimental drug or biologic) is performed in Human Subjects in the United States or intended to support a United States licensing action.

Investigational New Drug Application means an application for an "Investigational Exemption for a New Drug' filed with the United States Food and Drug Administration or any successor' drug-regulatory entity thereto ("FDA") or the corresponding application filed with the equivalent pharmaceutical regulatory agency in France, Germany, Great Britain, Italy or Japan.

Investigational New Drug Application or “IND” means the petition filed by YM with the FDA requesting the FDA to allow human testing on the Investigational Product.

Investigational New Drug Application. (“IND”) means an application filed with the FDA pursuant to 21 C.F.R. § 312.1, et seq. (as defined in 21 C.F.R. § 312.3), or its foreign Agency equivalent, and all supplements, amendments, and revisions thereto, any preparatory work, drafts, and data necessary for the preparation thereof, and all correspondence between Respondent(s) and the FDA or other Agency relative thereto.