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Zdrowie i gospodarka · 5/23/2002

Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Carcinogenicity Study Protocol Submissions." This document is intended to provide guidance on the types of information the Center for Drug Evaluation and Research (CDER) relies on when evaluating protocols for animal carcinogenicity studies.

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