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Wang D, Zhang Y, Li Q, Zhang A, Xu J, Li Y, et al

[643] At 427.101(b)(5) we proposed to codify existing policy to exclude cellular- and tissue-based products that aid wound healing, currently referred to as skin substitutes, for the purposes of identifying Part B rebatable drugs

Therapeutic Equivalence Evaluations Equivalence Codes : The Orange Book provides therapeutic equivalence evaluations for generic drugs, indicated by specific codes