Throughout the drug development and product approval process, CMC executives have a limited number of opportunities to engage with FDA to discuss areas of concern requiring clarification, making FDA meetings a pivotal opportunity. The role for CMC executives within these meetings is often ambiguous and pin pointing the essential CMC information to extract from these sessions is a common challenge. The following presentation will discuss what to anticipate from these meetings and how to conduct the meetings in a consistent and efficient manner.
- Ensuring CMC teams are integrated in FDA meetings
- Timing meetings with FDA to ensure questions are clarified
- Defining FDA expectations for pre-submission CMC data
Stephanie Krogmeier, Ph.D.
Sr. Director, Regulatory Affairs CMC