Reviewer guidance [[electronic resource] ] : conducting a clinical safety review of a new product application and preparing a report on the review

• Record Nr.: UNINA9910699113103321
• Pubbl/distr/stampa: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2005]
• Descrizione fisica: 1 online resource (79 pages)
• Soggetti: Clinical trials - Reporting - Government policy - United States; Drug approval - Government policy - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: "Good review practices."; "February 2005."