Investigational new drug (IND) application
Juan Cedeno-Serna
Abstract
The goal of translational biomedical research is to introduce a new experimental medicine or device to market. The Food and Drug Administration (FDA) has created a protocol to follow once a medication has been assessed for pharmacological activity and acute toxicity in animal models and is ready to be tested in clinical trials to evaluate its therapeutic potential in Humans. The investigational new drug application (IND) is the most crucial document that must be submitted to the FDA to ship the investigational new drug and proceed with clinical phase 1, 2, and 3 clinical trials . Fields like regenerative medicine and nutritional supplementation have all seen significant growth in sports medicine , making knowledge of the fundamental principles of IND a prerequisite for investigators working in translational research in sports medicine .