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

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Subjects: Monoclonal antibodies--Therapeutic use--Government policy--United States
Orphan drugs--United States
Formats: Electronic Resource, Remote
Material Type: Books
Language: English
Audience: Unspecified
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]
Physical Description: 1 electronic resource (i, 5 p.)
Alternate Titles: Portion of title: Interpreting sameness of monoclonal antibody products under the orphan drug regulations
Additional Authors: Center for Biologics Evaluation and Research (U.S.)
Center for Drug Evaluation and Research (U.S.)
Notes: "Draft guidance."
"July 1999."
Includes bibliographical references ( p. 5)
OCLC Number: 567509206