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12:00 AM
Sep 17, 2007
 |  BioCentury  |  Regulation

QOL claims

QOL claims

QOL claims
When FDA approved modifications to the labels of ESAs in March, it asked Amgen to reassess the data supporting inclusion of the quality of life information presented in the Clinical Experience section of the epoetin alfa label for Epogen and Johnson & Johnson's Procrit to determine if they meet the standards in the agency's draft guidance on Patient-Reported Outcome Measures...

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