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Pharmacological substances not approved for human therapeutic use by any governmental regulatory authority are included in this category

Section 1861(pp)(1)(D) of the Act also authorizes the Secretary to include in the definition of CRC screening tests other tests or procedures, and modifications to the tests and procedures described under this subsection, with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations. 3

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1-10 mg/kg in animal studies KPV studies: 100 micromolar oral concentrations in colitis models