FDA Focuses On Animal Testing, Trial Endpoints In BPH Device Draft Guidance

 
• By Elizabeth Orr

Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.

At doctors appointment physician shows to patient shape of prostate gland with focus on hand with organ. Scene explaining patient causes and localization of diseases of prostate, problems and signs
• Source: Shutterstock

A new draft guidance document from the US Food and Drug Administration makes recommendations about clinical trials and other research of devices intended to treat benign prostatic hyperplasia (BPH), a common form of age-related prostate enlargement.

The 25-page draft, issued on 14 July, is intended to replace some sections of a 2010 guidance document on BPH...

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