USA – FDA proposes reporting rule for Right to Try Act

A new proposed rule issued by the US Food and Drug Administration (FDA) provides sponsors and manufacturers detailed guidance on the annual summary reporting required of them under the Right to Try Act.

“The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, in announcing the publication of the proposed rule. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.”…