publication date: Jan. 4, 2019

Real-World Evidence Fulfilling 21st Century Cures mandate, FDA lays out philosophy on real-world evidence—and recruits Amy Abernethy for No. 2 job

By Matthew Bin Han Ong

FDA has created a framework for evaluating the use of real-world evidence to support additional indications for already approved drugs as well as to satisfy drug post-marketing study requirements.

The framework lays out the fundamentals of the agency’s approach to developing guidances for using real-world data in drug regulation.

The report, published in December, as required by the 21st Century Cures Act, applies to drugs and biological products. It doesn’t apply to medical devices.

In addition to staking out a swath of the burgeoning field of real-world evidence, the agency has recruited Amy Abernethy, an expert in generating and applying real-world evidence, to the job of principal deputy commissioner, making her the second-highest ranking official at FDA.

“First of all, if you haven’t read [the framework], it’s really worth reading,” said Abernethy, who is now the chief medical officer, chief scientific officer and senior vice president of oncology at Flatiron Health. She is expected to start at the agency in February 2019, after leaving Flatiron.

A conversation with Abernethy appears here.

“I think that the major … Continue reading Fulfilling 21st Century Cures mandate, FDA lays out philosophy on real-world evidence—and recruits Amy abernethy for No. 2 job

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