Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing; Request for Comments

摘要

The Food and Drug Administration (FDA) is announcing a public hearing to solicit views and information from interested parties concerning the concept of electronic distribution of FDA-approved prescribing information currently contained in the package insert (or PIs) for human prescription drug and biological products. In particular, FDA is seeking views and information on the feasibility of establishing a modern and efficient process for industry to electronically distribute prescribing information to dispensers. We are seeking input on a number of questions regarding the current use of package inserts and those logistical issues associated with electronic distribution of such prescribing information.