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Guidance for industry : interpreting sameness of monoclonal antibody products under the orphan drug regulations.
- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Monoclonal antibodies--Therapeutic use--Government policy--United States.
- Monoclonal antibodies.
- Orphan drugs--United States.
- Orphan drugs.
- United States.
- Physical Description:
- 1 electronic resource (i, 5 pages)
- Other Title:
- Interpreting sameness of monoclonal antibody products under the orphan drug regulations
- Place of Publication:
- 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]
- Notes:
- "Draft guidance."
- "July 1999."
- Includes bibliographical references (page 5).
- OCLC:
- 567509206
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