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Big Data And The FDA: To Mine The Value, First Mind The Gaps

 
• By William Looney

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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Innovation is the spark of creation that waits for no one. Least of all for the regulator, whose reaction to something new is often to regulate it – usually after the need to regulate has passed.

That’s why it’s a surprise to see the FDA take the lead in tackling what’s arguably the key challenge to...

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