The Investigational New Drug (IND) application is a critical step in the development of new therapies, allowing researchers to initiate clinical trials for investigational drugs within the United States. This regulatory pathway, overseen by the U.S. Food and Drug Administration (FDA), ensures that proposed treatments are safe for human testing and that the study design protects trial participants. A successful IND application is essential for advancing innovative therapies from the laboratory to the clinic. This article outlines the key components and requirements for submitting an IND application.
Essential Requirements for a Successful IND Application
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