Pitfalls Of Chemistry, Manufacturing, And Controls In Investigational New Drug Preparation

By Steve Pondell, Managing Expert, Regulatory Center of Excellence

Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug to market in the U.S. Too often, though, the chemistry, manufacturing, and controls (CMC) aspect of the IND are not fully considered until it is too late, resulting in a delayed IND submission or even a clinical hold letter from the Food & Drug Administration (FDA). To understand more about how these roadblocks may impact an IND, this blog outlines three common CMC pitfalls.