Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Naloxone Mandate In Opioid Labels Divides US FDA Panel, Even As It Wants Patient Conversations
Advisory committee members vote narrowly in favor of labeling opioids with a recommendation to co-prescribe naloxone, but more agree that the goal is to facilitate patient-provider dialogue about overdose risks.
Cost Concerns May Hinder Naloxone Co-Prescribing Ideas
US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.