Posted by Michael Wonder on 15 Sep 2022
FDA issues final rule on ‘right to try’ reporting requirements
14 September 2022 - 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.
