Zdrowie i gospodarka · 7.11.2000
Draft Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Carcinogenicity Study Protocol Submissions."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 relies on when evaluating protocols for animal carcinogenicity studies.