Learning To Love The “CFL”: US FDA’s New Communication Policy

Final guidance on communication “consistent with the label” is noteworthy for how closely it follows Obama-era draft. That may be a surprising twist given the background of the Trump-era FDA Commissioner and HHS Secretary – but on balance is probably the best possible approach for maintaining the current FDA approval climate.

Communication - old telephone

The US FDA’s decision to finalize a promotional guidance defining a new class of permitted claims that are “consistent with the label” is probably disappointing to some advocates for broad readings of the First Amendment as it applies to drug company communications.

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A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

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Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

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Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.