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.
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