For only the second time, the Food and Drug Administration is threatening to fine a drug maker for failing to submit required information about a clinical trial to a U.S. government registry.
In a July 26 letter, the agency noted results of Phase 2 clinical test of a drug for treating acne rosacea had not been posted, even though the FDA contacted Accuitis last October about the issue. Acne rosacea is a condition that causes pus-filled bumps on the face and mostly affects middle-aged women with fair skin. Accuitis now has until Aug. 26 to post the data.
Rick Coulon, the chief executive officer of Accuitis, told us the company “will be in full compliance with the FDA by the deadline stated,” but declined to answer other questions.
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