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10.3390/biomedicines11020448 27 DaiL.WangL.DengL.LiuJ.LeiJ.LiD.et al (2014)

Mechanism-focused studies may include receptor-pathway assays, biomarker panels, gene-expression analysis, protein-expression studies, cell-viability controls, migration assays, metabolic marker analysis, or stability testing

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10.1016/j.drudis.2010.01.009 121 MessiaenA

In the FY 2021 IPPS/LTCH PPS final rule, to more precisely describe the various types of FDA approvals, clearances and classifications that we consider under our new technology add-on payment policy, we finalized a technical clarification to the regulation to indicate that new technologies must receive FDA marketing authorization (such as pre-market approval (PMA)