Guidance for industry [[electronic resource] ] : interpreting sameness of monoclonal antibody products under the orphan drug regulations

• Record Nr.: UNINA9910696912203321
• Pubbl/distr/stampa: 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]
• Descrizione fisica: 1 electronic resource (i, 5 pages)
• Soggetti: Monoclonal antibodies - Therapeutic use - Government policy - United States; Orphan drugs - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: "Draft guidance."; "July 1999."
• Nota di bibliografia: Includes bibliographical references ( page 5).