What must occur after filing an IND?

After filing an Investigational New Drug (IND) application, the next step involves conducting Phase I clinical trials. The IND is a crucial submission to the FDA that provides the necessary information about the drug to ensure it is safe for initial use in humans. Once the FDA reviews and does not object to the IND within a specified timeframe (typically 30 days), the sponsor can proceed to initiate clinical trials.

Phase I trials are primarily focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in a small group of healthy volunteers or patients. This phase is essential for establishing a foundational understanding of how the drug behaves in the human body before advancing to the larger and more complex Phase II and Phase III trials, which further evaluate efficacy and safety.

Conducting animal testing is generally required prior to filing an IND and is part of the preclinical phase to assess safety and biological activity. Obtaining marketing rights happens later, after successful completion of all trial phases and FDA approval, while terminating drug development would not be an action taken after filing an IND; instead, it's an endpoint reached if the drug proves ineffective or unsafe during trials.