US FDA To Publish Own Datasets In Latest Signal Of Enhanced Transparency
Adverse event reporting data will also be more readily available, Commissioner Scott Gottlieb says.
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Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.
The current FDA commissioner discussed use of the social media platform with his predecessor Robert Califf at a meeting on real-world evidence.
'Believe it or not, we don't have as many disease-specific guidances as you would suspect on the new drug side,' Commissioner Gottlieb says.