Capricor Therapeutics is raising issues with the U.S. Food and Drug Administration's new policy of publishing rejection letters sent to drugmakers. The FDA in June began publishing older letters, ...

The FDA today announced a plan to publicly release complete response letters at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency ...

The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response ...