The chemistry manufacturing and controls (CMC) section of an Investigational New Drug (IND) application contains the manufacturing details of the investigational drug product. During the IND process questions from the FDA reviewers about the CMC section are not uncommon, and can lead to the IND being put on clinical hold until the questions are answered. In this session, three cellular therapy professionals experienced in the IND application process will review some common pitfalls of CMC sections, providing examples of real FDA questions and successful responses. Ideas and suggestions for submitting CMC sections that anticipate and answer the most common questions will be discussed.