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…will have an opportunity to provide oral comments during the public meeting as well as written comments to the docket. Comments previously submitted in response to the July 12, 2018…
…Narcotic Drugs, 1961 (“Single Convention”), the Agency’s action must comport with the requirements of the treaty. Cannabis, cannabis resin and extracts and tinctures of cannabis are listed in Schedule I…
…completed and pending oral argument. Meanwhile, the FTC is facing a ViroPharma problem. Courts are re-examining their historical reliance on the Commission’s assertions that, pursuant to section 13(b), a defendant…
…high-stakes regulatory submissions, Mike has litigated a number of significant Hatch-Waxman matters arising from the award or denial of 180-day exclusivity, 3-year and 5-year exclusivity, orphan drug exclusivity, 30-month stays,…
…3588 (S.D.N.Y. Mar. 8, 2016), Pacira Pharms., Inc. v. FDA, No. 15 Civ. 7055 (S.D.N.Y. Dec. 15, 2015), and United States v. Vascular Sols., Inc., No. 5:14-CR-00926 (W.D. Tex. Feb…
Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen. As…
…Diversion Control Division secure network application. Of note, one commenter requested that the reexport provisions should apply to EEA member countries as of November 25, 2015, noting that the United…
…to commit adulteration under the Federal Food, Drug, and Cosmetic Act (“FDC Act”). Based on a complaint by Dr. Kaplan’s own medical assistants to the Nevada State Medical Board, FDA’s…
…on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as…
…California Business and Professions Code §§ 17200 and 17500, and California unfair competition and misappropriation common law in that they “unlawfully and unfairly advertised, marketed, promoted, distributed, and/or sold in…
…in Teva Pharms. USA, Inc. v. Novartis Pharma. Corp., in which the court, consistent with the Supreme Court’s Medimmune decision, rejected the “reasonable apprehension of imminent suit” test the court…
…(2) offers some pro-competitive benefit.” The K-Dur Petitions have already drawn significant attention. Amicus briefs have been filed by PhRMA, GPhA, the Washington Legal Foundation, Bayer Corporation, and the New…
…are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bearsprimary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act…
…Letters to Cody and Lannett (among other companies) to stop manufacturing certain unapproved narcotic drugs, including morphine sulfate oral solutions. At that time, FDA concluded that marketed unapproved morphine sulfate…
…found FDA’s August 18, 2014 Letter Decision permitting the approval of ANDAs for generic PRECEDEX not arbitrary, capricious, or otherwise not in accordance with law, but rather, a decision based…