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Off-Label Promotion Decisions Likely Made Case-by-Case, US FDA Official Says

 
• By Derrick Gingery

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.

Sponsors are largely being left to their own devices when determining information is "consistent with" FDA-approved drug labeling, at least for now, as the agency plans a case-by-case approach.

The agency's inability to provide more general clarity may force sponsors to watch for enforcement action from the US agency or wait for individual

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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
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