We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Issues Revised ICH Risk-Benefit Submission Guidance
FDA Issues Revised ICH Risk-Benefit Submission Guidance
The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions.