FDA Guidance On Health Care Economic Data Is Coming In 2015
This article was originally published in The Pink Sheet Daily
Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.
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However, FDA lacks funding to promptly respond to off-label promotion submissions on broad scale; model outlined in settlement of Amarin's Vascepa case could bolster support for third-party vetting system.
FDA settlement with Amarin on Vascepa has done little to clarify what constitutes 'non-misleading' communications about an unapproved use.
Amarin may submit up to two proposed communications annually to FDA about unapproved use of its triglyceride-lowering drug Vascepa, and the agency must respond with any concerns within 60 calendar days.