FDA Estimates Annual IND Safety Reports at 25,000

Safety and adverse event reporting take up the majority of time clinical trial sponsors and investigators devote to reporting and recordkeeping related to IND regulations each year, FDA figures show. For example, sponsors send more than 25,000 safety reports on INDs and follow-up submissions annually to the FDA and investigators, which takes sponsors a total of 809,000 hours, the FDA says.
Washington Drug Letter