Vanda’s Tasimelteon Gets Panel OK: “A Well-told Story That’s Plausible”
This article was originally published in The Pink Sheet Daily
FDA advisory committee supports using secondary endpoints to establish clinical benefit of treatment for non-24 sleep-wake disorder.
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Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.
Stakeholder meeting will address poor enrollment rates and other issues that undermine the utility of pregnancy registries, as well as the use of alternatives, such as case control studies and claims-based database studies.