FDA Guidance: Testicular Toxicity

Posted by Tracy Hendershott on Nov 26, 2018 9:29:00 AM

 

Testicular Toxicity

After being in the draft stages for approximately three years and continuing to receive industry feedback, the FDA CDER has just released final Guidance for Industry Title Testicular Toxicity: Evaluation During Drug Development in October 2018. There are numerous challenges with conducting multi-center clinical trials focusing on testicular toxicity and yet remaining within the realm of guidance from the FDA per their statement:

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Tags: FDA, Testicular Toxicity, Central Laboratory, Clinical Trial