Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use" [electronic resource].
Imprint
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [1999]
Submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use"
Application to market a new drug, biologic or an antibiotic drug for human use
