Monthly Archives: September 2010

On September 17, 2010, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) issued a notice in the Federal Register requesting public comment on a proposed new program referred to as “parallel review” (“Comment Request”).[1] This program would give drug and device sponsors the option of receiving an FDA premarket evaluation and a Medicare National Coverage Determination at the same time. By reducing the waiting times associated with CMS and FDA product evaluations and decreasing the likelihood that product sponsors will have to conduct separate clinical studies for each agency, CMS and FDA believe that parallel review will hasten consumer access to new innovative products and minimize the burden that FDA reviews and Medicare National Coverage Determinations impose on drug and device sponsors. These changes will not only affect parties who are interested in drug and device innovation, but providers, payers, and health care consumers as well.