Electronic Distribution of Prescribing Information for Prescription Drug Products; Reopening of Comment Period

概要

The Food and Drug Administration (FDA) is reopening to December 6, 2007 the comment period for the notice that published in the Federal Register of April 2, 2007 (72 FR 15701); this notice was related to the public hearing of April 27, 2007, concerning the electronic distribution of FDA-approved prescribing information currently contained in the package insert (PI) for prescription drug and biological products. FDA is reopening the comment period for the sole purpose of inviting interested persons to submit comments on the concept of electronic distribution of FDA-approved prescribing information currently contained in the PI for prescription animal drug products.