Off-Label Promotion Ruling Increases Pressure For FDA Policy Change
Amarin’s court-approved disclosures could serve as a model that would allow manufacturers to discuss data while also giving FDA input and oversight.
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Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.
Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.
Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.