IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more
Share on Twitter Print Share Back to top The Patent Term Extension (PTE) provisions of 35 U.S.C. 256 were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984. PTE partially compensates...more
FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications....more
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often accuse brands of improperly trying to extend their monopolies over patented...more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As...more
The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more