Gilead and Novartis seek to expand what FDA considers as real-world data and real-world evidence

RAPS

15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes real-world data and real-world evidence and how to submit such data to the agency.

The draft guidance spells out what the agency considers to be an real-world data (RWD) source (i.e. electronic health record data, medical claims or billing data, etc.) and what relevant submissions may include real-world evidence (RWE) (i.e. single arm trials that use RWE as an external control, observational studies that generate RWE to support an efficacy supplement or observational studies using RWE to fulfil a post-marketing requirement, etc.).

But biopharma companies Gilead and Novartis are calling on FDA to expand on its sources of RWD and the scope of RWE, even as some physicians and experts have cautioned against using RWD and RWE for regulatory decisions or as a replacement for clinical trials.

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Michael Wonder

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Michael Wonder