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FDA needs to amend fine schedule, says GAO (General Accounting Office):

This article was originally published in Clinica

Executive Summary

Government auditors have criticised the FDA for failing to adjust its civil penalties to keep up with the rate of inflation as required by law. The General Accounting Office says that 14 of the agency's civil penalties need to be adjusted including penalties found in a 1968 radiation safety law, the Safe Medical Devices Act of 1990 and the Mammography Quality Standards Act of 1992 and its 1998 reauthorisation. The FDA says it is already preparing a draft regulation that would adjust the penalties by the maximum allowed of 10%.





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