This webinar aims to provide insights around the evolution of the pre-approval information exchange between manufacturers and payers. The session will present diverse perspectives from stakeholders as well as insights collected via the FormularyDecisions.com community – home of the AMCP eDossier System.
Presentations will include:
- Payer requests for preapproval information and current status of receiving the information
- Manufacturer challenges with providing preapproval information and recommendations for best practices
- Potential changes to the AMCP Format for Formulary Submissions to address FDA Final Guidance on communication of unapproved products and unapproved uses of approved products