US FDA Oncology Diagnostics Pilot Is ‘Interim Step’ To Fill VALID Void, But ‘Stuck In Neutral’
Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.
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FDA launches what it hopes will the final push to reform the regulatory oversight system for lab-developed tests by proposing a relatively rapid transition period to require essentially all LDTs to comply with the existing regulations for in vitro diagnostics. Legislation, litigation, and industry negotiation will likely shape the final product.
It is clear that the next step in the long-term debate over whether and how the US FDA should regulate lab-developed tests will come from the administration and not Congress. But key legislators are ready to move quickly if they can get enough support.
US FDA’s Cancer Drug/Diagnostic Pilot Program Aims To Close The Gap Between Regulation And Clinical Practice
Laboratory-developed tests may be misidentifying patients for treatment with targeted therapies. Under a new initiative, the FDA will work with sponsors to develop minimum performance characteristics for LDTs that may be used with an approved cancer drug in clinical practice.