Guidance for industry : interpreting sameness of monoclonal antibody products under the orphan drug regulations.

Bibliographic Details
Corporate Authors:	Center for Biologics Evaluation and Research (U.S.), Center for Drug 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 : Center for Drugs Evaluation and Research, [1999]
Subjects:	Monoclonal antibodies > Therapeutic use > Government policy > United States. Orphan drugs > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS120833

Available Online