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Zdrowie i gospodarka · 28.06.1999

Draft Guidance for Industry on Changes to an Approved NDA or ANDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Changes to an Approved NDA or ANDA.'' This draft guidance is intended to assist applicants in determining how they should report changes to an approved NDA or ANDA under the proposed revision to the drug regulations pertaining to supplements and other changes to an approved application published elsewhere in this issue of the Federal Register.

Source: Federal Register — Food and Drug AdministrationOpen original release →