Investigational New Drug Application definition

Investigational New Drug Application or “IND” means Investigational New Drug Application as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any corresponding foreign applications, registration or certification.

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.

Investigational New Drug Application means an investigational new drug application, as defined in 21 C.F.R. Section 312.3, obtained for purposes of conducting clinical trials in accordance with the requirements of the United States Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, including all supplements and amendments thereto.

Examples of Investigational New Drug Application in a sentence

• 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.

• To the extent required by applicable Laws 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 when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

• To the extent required by applicable laws and regulations of the FDA, the Company 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.

• An investigational agent is a protocol drug administered under an Investigational New Drug Application (IND).

• 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.

More Definitions of Investigational New Drug Application

Investigational New Drug Application means an application for regulatory approval by the FDA or its foreign equivalent in France, the United Kingdom, Germany or Japan, to commence human clinical testing of a drug, as defined by the FDA or the foreign equivalent.

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 or “IND” shall mean an application submitted pursuant to FDCA 505(i) and described in 21 C.F.R. §312.23, and amendments and supplements thereto.

Investigational New Drug Application means a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration to administer an investigational drug or biological product to humans in compliance with the requirements set forth in 21 CFR 312 (or its successor regulation), or its foreign equivalent.

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 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") shall mean a request for authorization from the FDA or applicable regulatory authorities in other countries to administer an investigational drug or biological product to humans.