Guidance for industry [[electronic resource] ] : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes

• Record Nr.: UNINA9910696920003321
• Pubbl/distr/stampa: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004]
• Descrizione fisica: 1 online resource (2 pages)
• Soggetti: Drug approval - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: "CMC."; "November 2004."