Second-Guessing FDA: CMS’ Expanding Regulatory Role
Nothing gets biopharma policy watchers more worked up than the potential that the Centers for Medicare & Medicaid Services will second-guess FDA approval decisions. In reality, though, CMS often has no choice but to apply its own interpretation to issues that also fall under FDA’s jurisdiction-and the health care reform implementation is bringing more of those cases to the fore...
Check out the complete article by an award-winning journalist in the upcoming edition of ONCOLOGY...
