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Off-Label Communication Principles From PhRMA, BIO Aim For Reg Changes

Executive Summary

Manufacturer communications with providers and payers could include real-world evidence and pharmacoeconomic information, associations urge.

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Manufacturer Communications: Industry Seeks Single Evidentiary Standard

‘Competent and reliable scientific evidence’ standard for payer communications also should apply to medical product communications that are consistent with labeling, manufacturers say in comments on US FDA draft guidance documents.

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Off-Label Promotion: 'Safe Harbor' Preferable To Expansive Free Speech Rulings

Payer- and physician-directed communications would be best addressed through a regulatory 'safe harbor' rather than First Amendment challenges where the outcome might sweep up consumer-directed communications, lawyers say at FDA/CMS Summit.

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