“Discuss With Your Doctor” Can Be Misleading Promotional Claim, FDA Says
This article was originally published in The Pink Sheet Daily
Sunovion draws untitled letter for Brovana brochures that encourage patients to have conversation with their doctors about the shortcomings of competitors to the COPD drug.
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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.