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

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.