A Comparison of Instructions for Use Documents and Manufacturer Produced Administration Videos for Biological Products.
Vraj PatelKellie TaylorJames SchlickJohn B HertigPublished in: Therapeutic innovation & regulatory science (2023)
We suggest that when sponsors create or update MPAVs, to focus on aligning critical content between the respective IFU and MPAV. We believe that it is possible for MPAVs to potentially reduce medication errors as a non-text-based media form and that care should be taken to avoid substantial differences in critical content between the IFU and MPAV.