Tag: clinical data

clinical data

Regulatory/FDA

FDA Draft Guidance for Real-world Data: Documentation of Data Approach Is Key

FDA Draft Guidance for Real-world Data: Documentation of Data Approach Is Key

Oct. 25, 2021 –  Translating real-world data (RWD) into a standard format that the Food and Drug Administration (FDA) can process, review and archive will pose challenges that are best met with detailed documentation of a sponsor’s data approach, according to the agency’s draft guidance on data standards for drug and biological products submissions containing […]

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