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.
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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.
Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.
US FDA commissioner nominee Stephen Hahn does not offer much detail on his policy positions; Senate confirmation could be completed by the end of the year.