Investigational New Drug Application definition

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.

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.

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

means an application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder to the FDA or the equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence clinical testing of products in humans. For purposes of this Agreement it shall also include IDE's (Investigational Device Exemptions).