FDA Readiness: Strategic Considerations for a Successful Marketing Application Review Cycle and Product Launch

October 26, 2023 | 12:00 PM - 1:00 PM ET


Once pivotal clinical trials have been completed and an NDA or BLA has been submitted to FDA, sponsors must navigate ongoing FDA interactions while preparing for a potential product launch. During this time period, a coordinated, proactive plan within the company is key. In this session, we will discuss areas where strategic planning and action can help a sponsor successfully engage with FDA and position the company for the next phase of the program’s life-cycle, including negotiating post-marketing commitments, preparing for a REMS, labeling discussions with FDA, payor engagement, and establishing an internal review process for product promotional materials.

CLE credit will be offered for California, Minnesota, New Jersey, New York and Pennsylvania.