CDER explores series of draft guidances on real world data, real world evidence - drug information update

FDA

31 January 2022 - Collection and analysis of real world data continue to gain traction in the biomedical community, accompanied by a growing understanding of real world data’s strengths and limitations. 

Increased collection of real world data is leading to the generation of real world evidence that can potentially inform regulatory decisions regarding the safety and effectiveness of medical therapies. 

Such regulatory decisions include whether to approve the drug, what the drug’s indication(s) should be, and what safety protocols (if any) are necessary to ensure safe use of the product.

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Michael Wonder

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Michael Wonder