Federal Register Notice: FDA is making available a document, Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. It provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use. It finalizes a 9/06 draft guidance and replaces the information specific to viral vaccines for preventing and treating infectious diseases that the agency provided in the 1993 document entitled “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.” To download this guidance, click here. To view this notice, click here.