A second U.S. Food and Drug Administration (FDA) Warning Letter has been issued to a firm for alleged ClinicalTrials.gov reporting noncompliance violations. Georgia-based Accuitis, Inc. could be “subject to a civil monetary penalty of not more than $10,000 for each day of the violation” until the noncompliance is corrected, the FDA says in the July 26 letter.
Accuitis faces the financial penalties if it fails to satisfy FDA reporting requirements within 30 days of receipt of the Warning Letter, the agency said. The Accuitis trial at issue is focused on the efficacy of ACU-D1 in the treatment of acne Rosacea.
The letter to Accutis follows an April letter to Acceleron calling it out for alleged ClinicalTrials.gov reporting noncompliance.
“We take [compliance with ClinicalTrials.gov] requirements seriously,” Miah Jung, PharmD, a pharmacologist with the FDA, told CRbeat in June.
While the FDA “hopes for voluntary compliance,” the agency also wants regulated entities to understand the importance of compliance and the potential consequences of failing to meet regulatory expectations, adds Jan Hewett, BSN, JD, regulatory counsel (policy) with the FDA Center for Drug Evaluation and Research.
Edited by Michael Causey