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Zdrowie i gospodarka · 12/5/2019

Novel Excipient Review Program Proposal; Request for Information and Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in determining whether it should establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. The Agency hopes to obtain information and comments on several aspects of such a program before deciding whether to develop it.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →