Patient-Centered Promotion? Marathon's Non-Launch Of Emflaza Illustrates Challenge Of New Era
Can a company explain the situation surrounding a newly approved drug, including the effect of the indication on access, without violating off-label communication regulations?
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Legislation pending in US House Energy and Commerce Committee would exempt drugs treating diseases with less than 200,000 patients from needing to justify price increases.
Instead of creating new mandate, legislation tells FDA to outline how risk-benefit decisions could be influenced by a product's abuse potential under existing approval authority; final opioids package expected to reach the White House soon.
OPDP chief Abrams did not give many general tips for complying with guidance on off-label promotion 'consistent with' FDA-approved labeling, leaving sponsors to make own interpretations.