On May 8, 1996, you submitted an _____ for studies of _____ using an _____ (_____ hereafter “_____”). By letter dated June 7, 1996, (the _____ letter), FDA approved your _____ Under the _____ you may perform _____ to treat _____ for 300 patients at one institution. FDA also requested in the _____ approval letter...Read More

In addition, there was no assurance that the dispensing pump delivers accurate doses. For example, daily accuracy tests on the pump were not documented and the _____ software, revision _____ was not validated to verify installation, operation, and performance.Read More