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Triaging Health Risks in the Cosmetic World: FDA Says Let’s Start with Tattoo Inks

Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more

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