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Either way, if the FDA is not provided with the regulatory tools to take appropriate enforcement action against these new and emerging products marketed as PMTA Exempt, the FDAs authority and its capability to protect public health are further undermined
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We note that because section 1847A of the Act provides for payment limit calculations that differ between single-source drugs (as defined in section 1847A(c)(6)(D) of the Act and 414.902) and multiple source drugs (as defined in section 1847A(c)(6)(C) of the Act and 414.902), we are proposing different ways to determine payment limits for each, in cases in which only negative or zero manufacturer's ASP data is reported, to reflect these differences
established a new Certified Electronic Health Record Technology (CEHRT) use threshold requirement
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