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Zdrowie i gospodarka · 9/28/1994

Biologics; Technical Amendment

The Food and Drug Administration (FDA) is amending the biologics regulations by substituting the term ``supplement'' for ``amendment'' when referring to the submission of a change to an approved establishment license or product license application. This action is being taken to harmonize the regulations with terminology used in the Prescription Drug User Fee Act of 1992.

Original source language: Federal Register — Health and Human ServicesOpen original release →