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It is not yet clear whether these data driven methods for exploring beneficial and harmful drug effects are a genuine advance over traditional inferential approaches

The FDAs posture on off-label communication is understandable but incomplete for this scenario

Mojca Jensterle has received lecture honoraria from Novo Nordisk, Eli Lilly, Pfizer, Amgen, Novartis and Sanofi, and is an advisory board member of Novo Nordisk, Eli Lilly, Amgen and Pfizer