ADHD Advisory Committee Wants FDA-Defined Standards Before Clearing Abuse-Deterrent Stimulant Label
Panel on Arbor Pharmaceuticals' reformulated stimulant highlights the risks of trying to craft a new labeling niche without any FDA guidance or endorsement of the idea.
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FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.
Ahead of the vaccine advisory committee, requests to FDA range from public health groups opposing emergency use authorizations to industry seeking labeling guidance on EUA products.
US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.