Hahn's Priorities For US FDA Eschew Hot-Button Issues, Focus on Traditional Themes
Executive Summary
Promoting innovation, expansion of data use, and patient and consumer empowerment will affect agency work going forward, the FDA Commissioner said in his first all-staff address. Absent from his all-hands memo was drug pricing, opioids, or any other potentially political themes.
You may also be interested in...
Could Revisiting US Approval Decisions Become Less Rare?
While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available.
For Coronavirus, US FDA Is At The Podium But Not On The Task Force
The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.
Complex Generic Approval Delays Getting Congressional Attention
US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.