FDA: Guidance for Industry Endocrine Disruption Potential of Drugs: Nonclinical Evaluation

This draft guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation and Research (CDER) regarding nonclinical studies intended to identify the potential for a drug to disrupt the endocrine system.

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Narodowe Centrum Badań i Rozwoju

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