Vanda’s Tasimelteon: A Safe, Efficacious Drug In Search Of An Indication
This article was originally published in The Pink Sheet Daily
FDA reviewers seem positive, but advisory committee will consider whether Non-24 is bona fide sleep disorder with identifiable patients.
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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.