Pharma Compliance Officers Fret Over Sunshine Act Costs, Data Analytics
This article was originally published in The Pink Sheet Daily
Purdue exec calculates his department will pay about $675,000 to comply with the new law; companies are looking for new ways to analyze data to avoid getting into trouble with the feds.
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HHS Office of Inspector General’s Mary Riordan advises drug makers to analyze their speaker programs and consulting arrangements for possible kickback activities.
Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.