Guidance for industry [[electronic resource] ] : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act

• Record Nr.: UNINA9910699352803321
• Pubbl/distr/stampa: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [1999]
• Descrizione fisica: 1 online resource (ii, 22 pages)
• Soggetti: Pediatrics - United States; Drug approval - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: "Procedural."; "Revised, September 1999."