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BIO Submits Comments on Male-Mediated Developmental Risk

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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.</p>

BIO appreciates the release of this Draft Guidance. It provides clarity and insights on FDA’s recommendations for the assessment of developmental risks associated with administration of pharmaceuticals to males.