Pre-IND Meeting

A pre-IND (pre-Investigational New Drug) meeting is a formal discussion between a drug sponsor and the FDA’s Center for Drug Evaluation and Research (CDER) or the Center for Biological Evaluation and Research (CBER). This meeting is held before submitting an IND application and is designed to help sponsors prepare their submission by providing feedback on the design of preclinical studies, initial clinical trial design, product manufacturing, and quality controls. It is a crucial step in drug development, aimed at reducing the risk of a clinical hold and ensuring that the IND application is complete and well-prepared.