The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.”
We commend the FDA on releasing this Draft Guidance, which we believe is consistent with industry practices for “fixed” dose regimens. In particular, we agree that single-dose vials should not contain a significant volume beyond what would be considered a maximum dose for the expected use of the drug product (lines 125-126). However, we note that there is little new information provided in the Draft Guidance; instead it points to already established documentation without much additional clarification. We believe it would be beneficial for Sponsors if the Draft Guidance added additional clarification and discussion around these topics.