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FDAMA |
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This was followed by the Food and Drug Administration Modernization Act of 1997 (FDAMA), providing the most wide-ranging reforms in the FDA since 1938. charging FDA was not authorized to issue the rule under the Food and Drug Administration Modernization Act passed by Congress in 1997 (nor under the follow-up law, the Best Pharmaceuticals for Children Act of 2002). Lamberth found unconstitutional the parts of the Food and Drug Administration Modernization Act (FDAMA) of 1998 that regulate drug manufacturers' distribution of information on off-label drug uses. |
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