Real-Word Evidence Generation System Will Be A Priority For Califf As FDA Commissioner
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.
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FDA, CMS Working To Smooth ‘Baton Handoff’ From New Drug Approval To Reimbursement
FDA commissioner Robert Califf wants to develop a postapproval evidence generation system through ongoing collaboration with CMS. Public health experts say efforts by FDA and CMS to work more closely could result in greater clarity on trial designs early in development programs.
Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
Dr. Califf Returns To US FDA: What To Do First?
Acting commissioner Janet Woodcock will remain at the agency and become principal deputy commissioner when Califf arrives.