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FDA Off-Label Citations Disappear In Post-Caronia Enforcement Letters

Executive Summary

Office of Prescription Drug Promotion letters post-Caronia fail to cite off-label promotion, in contrast to previous years when about one-third to one-half of warning and untitled letters scolded companies for off-label violations.

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FDA Policy Power Challenged In House Questions On Untitled Letters

Oversight and Investigations Subcommittee Chairman Murphy wants to know if FDA is aware of consequences of publishing letters during stock trading hours. The Energy and Commerce Committee examines whether FDA use of untitled letters is “fair, effective and efficient in gaining compliance,” he says.

FDA Policy Power Challenged In House Questions On Untitled Letters

Oversight and Investigations Subcommittee Chairman Murphy wants to know if FDA is aware of consequences of publishing letters during stock trading hours. The Energy and Commerce Committee examines whether FDA use of untitled letters is “fair, effective and efficient in gaining compliance,” he says.

FDA Policy Power Challenged In House Questions On Untitled Letters

Chairman Murphy wants to know if FDA is aware of consequences of publishing letters during stock trading hours.

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