AMCP Format for Formulary Dossiers Series – History of Actions by the FDA Governing Communication Between HCDMs and Manufacturers
One driver for the new AMCP format was the FDA Final Guidance, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, which allowed for communication of information on unapproved products and unapproved uses of approved products from manufacturers to payors, formulary committees, and similar entities. But this new guidance is just the latest in a series of actions by the FDA to govern how manufacturers communicate with HCDMs about their products.
Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with adjusting your dossiers to meet the new guidance, let us know!