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.