Tissue-Agnostic Cancer Treatments: Can US FDA-Approved Diagnostics Limit Access?
ASCO official argues postmarket development of diagnostics may restrict patient use once added to the label.
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Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.
In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.
New oncologics bring CDER’s novel agent approvals count to 53 for the year.