NDAs/PLAs LACKING FINANCIAL DISCLOSURE INFORMATION WOULD BE REFUSED FILING
This article was originally published in The Tan Sheet
Executive Summary
NDAs/PLAs LACKING FINANCIAL DISCLOSURE INFORMATION WOULD BE REFUSED FILING under an FDA proposed rule on financial disclosure for clinical investigators, FDA Deputy Commissioner for External Affairs Carol Scheman said at the agency's Science Board meeting on Feb. 24. "If a firm refuses to certify or to disclose [financial arrangements]...we would refuse to file the application. We will not accept an application without a certification or a disclosure," Scheman said.