Searching Content indexed under Patent by Frederick Ball ordered by Published Date Descending.
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FTC Issues Report On Its Authority Under Section 5 Of The FTC Act To Challenge Pharmaceutical Drug Price Increases
On June 24, 2019, in response to a directive from Congress, the Federal Trade Commission (FTC) issued a report to the House and Senate Appropriations Committees on the use of the FTC's
United States
30 Jul 2019
Case Study: Jazz Pharmaceuticals v. Amneal Pharmaceuticals
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, an appeal of six inter partes review decisions by the PTAB's finding that certain claims of seven patents ...
United States
18 Oct 2018
FDA Issues Final Hatch-Waxman Regulations
The FDA issued a Final Rule to implement provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, entitled "Abbreviated New Drug Applications and 505(b)(2) Applications."
United States
13 Oct 2016
Third Circuit Holds That Settlement Agreements Containing Payments From The Innovator To The Generic Challenger May Violate Antitrust Laws
On July 16, 2012, the U.S. Court of Appeals for the Third Circuit, which includes Delaware, New Jersey and Pennsylvania, issued a long-anticipated decision in In re K-Dur Antitrust Litigation, finding that settlement agreements in which payments are made to the generic manufacturers challenging the patents to settle the litigation may be unreasonable restraints on trade and unenforceable under federal antitrust laws.
United States
30 Jul 2012
OIG Reports On FDA Generic Drug Review Process - Pharmaceutical Manufacturers And Sponsors Be Aware
On June 13, 2008, the Office of Inspector General for the U.S. Department of Health and Human Services (the "OIG") released its report entitled "The Food and Drug Administration's Generic Drug Review Process."
United States
25 Jun 2008
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