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
To access this members-only content, please log in.
If you're not a subscriber why not join today?
If you believe you should be able to view this area but cannot log in, then please contact us
and we will try to rectify this issue as soon as possible.
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.