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. As a result, the FDA has stated publicly that they intend to make systematic changes to the process, including, but not limited to, the necessity of the committee vote, the timing and format of the meetings, and finding the ‘right’ experts for the panel at these AdCom meetings.
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 Learning Objectives:
- Attendees will be able to identify the potential changes to be made by the FDA to AdCom meetings
- Attendees will be able to identify the implications of these potential changes to their business and clinical development models
- Attendees will be able to identify potential strategies to prepare for the coming changes to FDA Advisory Committees
March 28, 11:00am-12:00pm ET