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June 30, 2023

FDA Announces New Pilot Program for Certain Cancer Treatments

On June 20, 2023 the FDA announced a new pilot program aimed at enhancing transparency for oncology treatments. Clinicians often use in vitro diagnostic tests to help them determine appropriate treatments for patients, but in some cases the FDA may approve an oncology treatment before its corresponding companion diagnostic is authorized. In such cases, laboratory developed tests (LDTs) are often used to fill the gap. The FDA hopes to improve patient care and transparency by establishing minimum performance characteristics for such tests through this program. The FDA’s final guidance regarding the program was published in the Federal Register on June 21, 2023. 

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