Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.

Bibliographic Details
Corporate Author:	Center for Drug Evaluation and Research (U.S.)
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]
Subjects:	Drug approval > United States.
Online Access:	Connect to online resource - All users (Federal Depository Library Program Persistant URL)
Physical Description:	1 online resource (2 pages)
Variant Title:	Changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes
Format:	Government Document Electronic eBook

System Under Maintenance

Our Library Management System is currently under maintenance.

Holdings and item availability information is currently unavailable. Please accept our apologies for any inconvenience this may cause and contact us for further assistance:

Please contact Reference and Discovery Services via their Contact Form or call them directly at: 517-353-8700 for assistance.

Online Access

Connect to online resource - All users (Federal Depository Library Program Persistant URL)