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In 2007, CMS issued a program instruction, [501] as permitted under section 1847A(c)(5)(C) of the Act, stating that the payment limit for a single source drug or biological will be based on the pricing information for products produced or distributed under the applicable FDA approval (such as a New Drug Application (NDA) or Biologics License Application (BLA))

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This situation undermines the credibility of the reported outcomes and highlights the need for independent, peer-reviewed research

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