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FDA approves first biosimilar drug for US

USA - March 9 2015 On March 6, 2015, the U.S. Food and Drug Administration (FDA) approved the first biosimilar product under the Biologics Price Competition and…

Sara Koblitz.

FDA proposing new rules to adjudicate Orange Book patent disputes

USA - February 12 2015 At long last, FDA proposed rules to implement the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA). For the most part, the…

The patent use code conundrum – or why FDA can’t read (patents)

USA - November 14 2014 Recently, FDA permitted generic manufacturers to carve out language from the labeling of generic versions of Hospira's Precedex even though the…

Sara Koblitz.

FDA issues draft guidance deregulating select medical devices

USA - June 20 2014 On June 20 the FDA issued a draft guidance essentially deregulating Medical Device Data Systems, Medical Image Storage Devices, and Medical Image…

Regulatory alert: new FCC rules require part 5 experimental licenses

USA - January 28 2014 In 2013, the FCC adopted a Report and Order, with an important Erratum, that widely revamped the Part 5 Experimental Radio Service (ERS). The new…

Donna A. Balaguer, Jay S. Newman.