Zdrowie i gospodarka · 23/11/1999
Guidance for Industry on Changes to an Approved NDA or ANDA; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Changes to an Approved NDA or ANDA.'' This guidance is intended to assist applicants in determining how they should report changes to an approved new drug application (NDA) or abbreviated new drug application (ANDA).