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…the proposal.” 85 Fed. Reg. at 62,112. According to the Plaintiffs, Section 804 does not contemplate or permit this SIP-by-SIP determination. In addition, the Plaintiffs argue that there is no…
…interest in granting a stay.” McCammon v. United States, 584 F. Supp. 2d 193, 197 (D.D.C. 2008) (citing United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 988,…
…(Triangle). FDA issued this order based on its finding that several Triangle products contained kratom that tested positive for salmonella. FDA issued the order after the company failed to respond…
…Administration (“DEA”) is proposing to implement a single-sheet order form. New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222), 84 Fed….
…here – would harmfully undermine the authoritative character of federal safety decisions designed to have national effect. . . . Second, the Massachusetts order plainly conflicts with the scientific predicates…
…payment model under the auspices of the CMS Center for Medicare and Medicaid Innovation (CMMI). See 42 U.S.C. § 1315a(b). (Click here for our post on the ANPR.) HHS has…
…the FTC Staff’s cross appeal. As a result, the final order is broader than the order issued by the ALJ in 2012. Specifically, the Commission concluded that: 36 (compared to…
…180-day, real-time or panel track supplement to FDA; and For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada….
Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones…
…results of the November election. The three executive orders and the possible fourth are described below. Executive Order on Importation of Drugs One Executive Order directs HHS to complete its…
…USA” enforcement program. The agenda is posted here. The comment period for written comments closes on October 11, 2019. We will be monitoring further developments regarding Made in USA claims….
By Kurt R. Karst – The dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products…
…requirement for any disease claim.” Id. at 38. It ruled that the FTC failed to justify a “categorical floor of two RCTs for any and all disease claims.” Id. In…
…appropriate only when there is a scientific and/or medical dispute related to a final order. A proposed order or an interim order is not an appropriate subject for an FDR….
…to Gilead Sciences Inc. (“Gilead”) “based on the apparent ineligibility of U.S. Patent No. RE 44,599 [and U.S. Patent No. RE 44,638] for [PTE] request under 35 U.S.C. § 156.”…