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Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907
Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907
FDASIA Section 907 directed FDA to report on the extent to which demographic subgroups (sex, age, race and ethnicity) participate in clinical trials in marketing applications for drugs, biologics, and devices. This report provided an important opportunity to take a closer look at the inclusion and analysis of demographic subgroups.