Zdrowie i gospodarka · 27/01/2022
FDA Releases Draft Guidance on Revised Abbreviated New Drug Application Labeling
The Food and Drug Administration (FDA) has published a draft guidance for industry on revising labeling for abbreviated new drug applications (ANDAs) following revisions to the reference listed drug (RLD) labeling, providing recommendations for updating ANDA labeling to conform to RLD labeling updates.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →