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FDA, CMS parallel review process a 'game changer'
ORLANDO, Fla. — A parallel review system recently launched as a pilot program by the Centers for Medicare and Medicaid Services and the U.S. Food and Drug Administration is a major "game changer," according to a speaker here.
"Think about coming to the two agencies when you are going to do your clinical studies," Jeffrey Shuren, MD, JD, told colleagues at the Ophthalmology Innovation Summit. "If you can account for both of our needs in one study, you may avoid [spending] a lot of time and effort and money."
The pilot project allows manufacturers to approach both the CMS and the FDA about a new product rather than getting approval from the FDA and then potentially retesting for the CMS, said Dr. Shuren, who is director of the FDA's Center for Devices and Radiological Health.
Such an effort could result in companies saving millions of dollars and several years of testing, Dr. Shuren said. One company discovered its planned FDA testing would satisfy the CMS by adding a few Medicare customers to the testing. The information allowed the firm to combine several trials into one, he said.
- Disclosure: Dr. Shuren is the director of the FDA's Center for Devices and Radiological Health.