Big Data And The FDA: To Mine The Value, First Mind The Gaps
INFORMED is a new initiative at the FDA to incubate new ideas in applying big data to boost the scientific, economic and social returns from the regulation of drugs and medical devices, with a particular focus on cancer.
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Some of the loudest messages from UK government's Life Science Sector Deal was the importance of using real world evidence - and the uniqueness the British health ecosystem can offer to trail blazing innovation.
Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.