Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse
Survival benefit seen in GlaxoSmithKline’s IMPACT study may be due to negative effects of abrupt withdrawal of inhaled corticosteroids for some patients instead of benefits of the triple-combination therapy itself, advisory committee members said.
COVID-19 Vaccine Advisory Committee May Help Determine US FDA Approach To Licensure
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.
Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide
Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.