Off-Label Worries Could Be Solved By Studies, Not Speech Reg Overhaul, FDA Suggests
This article was originally published in The Pink Sheet Daily
FDA says Par’s suit challenging its off-label promotion regulations is unfounded since the agency would not take action against speech to doctors who prescribe Megace ES for both approved and unapproved uses. FDA also lays out the rationale for its off-label promotion rules from DESI to Prempro.
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Parties have stayed their litigation as they continue to hammer out a potential global resolution that would also settle DoJ’s investigation of Megace sales and marketing practices.