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FDA releases new guidance for drug and biological product data

October 25, 2021


The US Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”

The 21st Century Cures Act was signed in 2016 and is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the 21st Century Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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