Planning Your IND: When And Why To Engage The FDA

Sponsors often delay FDA engagement during early drug development, believing they must first amass extensive data. However, the right time to begin planning for an Investigational New Drug (IND) application is when proof-of-concept data, clinical goals, and funding align. This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials, even if early studies occur abroad.

Sponsors often underestimate the time needed for stability data and the complexities of nonclinical safety requirements, making early planning critical. A pre-IND meeting with the FDA is strongly recommended to clarify expectations, propose study designs, and resolve data gaps. By viewing the FDA as a collaborative partner rather than an obstacle, sponsors can streamline their path to clinical trials and improve the likelihood of regulatory success.