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".

Bibliographic Details
Corporate Author:	Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [1999]
Subjects:	Blood products > Evaluation > Government policy > United States. Drug approval > Government policy > United States. Biologicals > Evaluation > Government policy > United States. Antibiotics > Evaluation > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS113537

Available Online