Blog Manufacturing Patient-Centered Specialization 
FDA Law
OCTOBER 6, 2023
There is much to unpack, and we intend to do so in a series of blog posts. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) Change to the IVD definition First, the mechanics of the change.
FDA Law
JUNE 7, 2023
Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. In this case, the Supreme Court provided greater clarity on how to interpret that requirement.
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