Patient-reported outcomes are playing a growing role in cancer research and are poised to become an important part of regulatory review in drug development—and even routine clinical cancer care.
Expanded access or “compassionate use” programs allow patients to use investigational treatments, medical devices, or tests, before they have received FDA approval.
FDA’s approval of the first generic version of Copaxone for treating patients with relapsing forms of multiple sclerosis has industry insiders contemplating the impact on the generics market as well as payer coverage strategies.
Critics charge that the practice of adverse tiering to deter costly patients is violating the Affordable Care Act's coverage mandate.
Health plans and providers play a critical role in maintaining U.S. vaccination rates and can help reverse the recent MMR vaccination-rate decline, a factor responsible for the recent re-emergence of measles.