The US Food and Drug Administration (FDA) has publicly stated that they intend to make changes to the Advisory Committee (AdCom) meeting procedures.
Recent controversial regulatory decisions, public misunderstanding and misinformation about the emergency use approvals for Covid-19 vaccines, and a general mistrust of the drug approval process in general, serve as a catalyst for change.
Join us during this discussion as we highlight the key areas for potential change in the FDA AdCom process and implications for drug companies seeking approvals.
Key Webinar Discussion Points:
- The potential changes to be made by the FDA to AdCom meetings
- The implications of these potential changes to their business and clinical development models
- Potential strategies to prepare for the coming changes to FDA Advisory Committees
