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FDA Guidance for Industry: Environmental Assessment: Questions and answers regarding drugs with estrogenic, androgenic, or thyroid activity



This guidance is intended to supplement FDA’s guidance for industry on Environmental Assessment of Human Drug and Biologics Applications, issued July 1998 (the EA Guidance), by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity (E, A, or T activity) in environmental organisms.

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