The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA
Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.
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At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.
US FDA commissioner-nominee Califf calls for streamlining clinical trial bureaucracy, as well as open access to clinical data.
The cardiologist seeking another term as FDA commissioner has been working in the pharma industry since leaving the post, but Senators have tended not to question nominee's work history extensively during previous confirmation hearings.