08/05/2020

FDA Proposes New Rule on Reporting Requirements

July 23, 2020 - Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act. READ PRESS RELEASE