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FDA policy aims to smooth generic access to samples of branded drugs subject to REMS use restrictions

USA - December 16 2014 In a draft guidance published December 4, 2014, the Food and Drug Administration (FDA) has attempted to remove, at least in part, a legal hurdle…

Frederick R. Ball.

FDA goes purple on biologics and biosimilars: composes a variation on a theme of orange

USA - September 22 2014 Since the early 1980s, the pharmaceutical industry, as well as the pharmacy boards that control substitution at the state level, have relied on FDA's…

Vicki G. Norton, Ph.D..

Successful use of inter partes review to cancel claims asserted in parallel litigation

USA - March 26 2014 In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next…

Siegfried J.W. Ruppert, Ph.D, Vicki G. Norton, Ph.D..

Court offers insights on when the 271(e)(1) safe harbor applies to the use of patented technology in early – and late -- drug development

USA - March 11 2014 FDA-regulated firms -- drug, device, biologic or otherwise -- on both sides of the patent aisle concerned with the bounds of the "Safe Harbor"…

Vicki G. Norton, Ph.D..

FDA reverses -- partly -- its view on combination drug exclusivity ... Or how 1 + 1 = 5

USA - February 28 2014 Under the compromise reached in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act that created the Abbreviated New Drug…