Clinical Investigators' Financial Disclosures Might Become Public – Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA is signaling greater readiness to publicly disclose what was once considered proprietary information on the financial ties of clinical trial investigators.
You may also be interested in...
FDA May Disclose Clinical Investigator Financial Data In Product Approvals
Final guidance on drug sponsors’ responsibilities for financial disclosures related to clinical investigators who participate revises definitions of due diligence and covered clinical studies from the draft published in 2011, but retains FDA’s statement that it may include such disclosures in the documents released upon product approval for marketing.
Regulatory News In Brief
FDA released a final rule on protections for children in clinical trials and a final guidance on financial disclosures by investigators. More regulatory news.
FDA Unveils 21 Policy Changes To Increase Transparency With Public
FDA may publicly disclose more information on specific devices prior to marketing approval under a May 19 proposal to increase transparency