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Imprese · 12/02/19981 min di lettura
Draft Guidance for Industry on Environmental Assessment of Human Drug and Biologics Applications; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Environmental Assessment of Human Drug and Biologics Applications.'' This draft guidance is intended to provide information on when an environmental assessment (EA) should be submitted in support of a human drug or biologics application and recommendations on how to prepare EA's.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →