Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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FDA says it is unclear whether Purdue’s OxyContin abuse deterrent reformulation reduced opioid overdoses or had a net public health benefit. Briefing document for upcoming advisory committee meeting asks panel to discuss Purdue’s four postmarket studies but does not include voting question on possible change in labeling claims.
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Seven pharmacies have filed a lawsuit against the FDA claiming the agency exceeded its statutory authority in its final standard memorandum of understanding on interstate compounding and that the MOU will have an adverse impact on compounding pharmacies and patients.