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…FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks. FDA and FTC found that companies…
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC,…
…& Security Plan et al. v. Bristol-Meyers Squibb Co. et al., No. 12-cv-2238, (S.D.N.Y. June 3, 2013) (opinion), at 10. In addition, the court ruled that the savings program did…
…of factors, including the covered establishment’s nutrition labeling, the method . . . used . . . to determine the nutrition information, and the steps taken by the establishment to…
…in court. In one case – Vermont v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2005) – a federal court concluded that a state plan for importing drugs from…
…. . . [P]laintiffs filed this lawsuit because they are upset that the 2013 Amendment allegedly ‘authorizes’ foreign commerce at the expense of in-state commerce. Even assuming that were true,…
…Congress.’” Arizona, 132 S. Ct. at 2501 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). Focusing on the Plaintiffs’ contention that the MPA Amendments violate the Supremacy Clause, U.S….
…Canada will use for a biologic that is similar to an approved innovator biologic. In Canada these product are referred to as “Subsequent Entry Biologics.” By Kurt R. Karst …
Colorado and Florida have joined Vermont in the list of states seeking to combat high prescription drug prices by establishing programs to import drugs from Canada. On April 29, 2019,…
…sort by “ID number” to group dockets together. In Beta, you have to separately search “Documents” and “Comments.” That means running each search twice . . . . and reviewing…
…obtain informed consent from research subjects. 21 C.F.R. § 50.20. However, it is typically the responsibility of the sponsor of an applicable clinical trial to post the information to www.clinicaltrials.gov. …
…(see here and here), Maine must obtain approval and certification for the proposed wholesale drug importation program from the U.S. Department of Health and Human Services. The state’s request for…
…proposed regulation stage. A similar international reference price approach is included in H.R. 3, the drug pricing bill passed by the House on December 12, 2019. The details of this…
…a solution to companies that have discontinued ANDAs for drug products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com; and https://www.andarepository.com/) is offering what we can only characterize…
…receive a discount) at www.AmericanConference.com/Cosmetics, or contact Bolam Kim (B.Kim@americanconference.com) directly to attend. Please be sure to use discount code S10-866-866L16.S to register and receive 10% off the tuition fee. …