BIO Submits Comments on Draft Testicular Toxicity Guidance
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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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Testicular Toxicity: Evaluation During Drug Development</p>
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Testicular Toxicity: Evaluation During Drug Development.
BIO appreciates the release of this Draft Guidance and we believe that the Draft Guidance will assist Sponsors to evaluate the potential for testicular toxicity. It would be helpful to Sponsors for FDA to include additional clarity regarding nonclinical safety margins, the conduct of clinical trials in men of reproductive age, and when to conduct a clinical trial to assess the impact of a drug candidate on the testes.
