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 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 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.

Examples of Investigational New Drug Application in a sentence

• This new generation products are still at the pre-clinical trial stage, and is anticipating the filing of Investigational New Drug Application (IND) with the FDA in 2020.

• Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).

• The Awardee will serve as the Sponsor of the Regulatory Application (an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this agreement.

• Before commencing clinical trials in humans, we must submit and receive approval from the FDA of an Investigational New Drug Application.

• Subject to further negotiation between the parties and set forth in the SOW, the Contractor may serve as the Sponsor of the Regulatory Application (an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this agreement.

More Definitions of Investigational New Drug Application

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 or “IND” means 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 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 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) 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. (“IND”) means the 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.