Monday, June 25, 2018

Perrigo missed FDA deadline for Testosterone Gel study: Commissioner

Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration, tweeted on June 22: “We have advised Perrigo that it failed to comply with #FDA postmarketing requirements for a study intended to determine the cardiovascular effects of testosterone replacement therapy product, Testosterone Gel, by the agreed upon deadline.” With the tweet, he attached a link to a letter sent to Perrigo that was posted to the FDA website.

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