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Testosterone CV Safety, From Signal To Label

 
• By Bridget Silverman

The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns

Postmarket safety evaluation of a product is rarely simple and direct. (Shutterstock)

The 15-year evolution of the US Food and Drug Administration’s review of the cardiovascular safety of testosterone replacement therapy showcases the intense work, consultation and and time required to assess uncommon but dire events like heart attacks in widely used products.

See the full story on the testosterone labeling changes

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Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
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