USA – FDA issues final rule on ‘right to try’ reporting requirements

Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a final rule issued this week.

The final rule specifies that manufacturers include details of the number of doses supplied, the number of patients treated, the use for which the drug was made available and any known serious adverse events that take place.

The rule also establishes when manufacturers need to submit reports. FDA said it has “extended the submission date for the first annual summary report from 60 calendar days after the final rule becomes effective as proposed to a specific date of March 31, 2023.”

The agency added that “this rule specifies that submissions must be made electronically. Currently, this means attaching a PDF document to an email. In the future, FDA may move to electronic submission through other direct means.”…