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HRD-83-24 1 (1983-04-05)

handle is hein.gao/gaobabdyo0001 and id is 1 raw text is: BY THE COMPTROLLER- GENERAL Seport To The. Congress OF THE UNITED STATES Legislative,And Administrative Changes Needed To Improve Regulation Of Drug Industry A considerable amount of misbranded and adulter- ated drug products get on the market because the Food and Drug Administration (FDA) does not have legislative authority to detain the products adminis- tratively prior to formal seizure action. The Congress should amend the Food, Drug, and Cosmetic Act to give FDA this authority. FDA has increased emphasis on voluntary compliance with regulations. However, FDA does not know the extent to which voluntary compliance is working. FDA needs to develop a mechanism to measure the extent to which allowing voluntary corrective actions prom- ised by firms violating FDA-administered laws and regulations result in compliance. This report also recommends actions FDA should take to reduce the number of proposed regulatory actions which are subsequently disapproved and to improve followup on unresolved deficiencies found in prior in- spections. HHS agreed with the recommendations and pointed out a number of corrective actions that are being taken. O~D S7>II li 1111 i 121021 GAO/HRD-83-24 APRIL 5, 1983 I

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