One of the most significant obstacles to drug competition is a patent listed in FDA’s “Orange Book.” The mere listing of a patent can delay competition for months, or even years, and drive up expense for competitors....more
Wednesday, January 17, 2018, 11:00 A.M. CST -- The FDA considers a product a drug-device if it includes at least two of the following: a drug component, device component, or a biologic component. The FDA does not classify as...more
Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more