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…Model for payment of certain drugs covered under Medicare Part B. 83 Fed. Reg. 54546 (Oct. 30, 2018). This is not the first time that CMS has attempted to test…
On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the…
…would provide savings to commercial health insurance customers. For 17 prescription drugs, VAHS determined that importation from Canada could result in annual savings between $1 and $5 million. However, VAHS…
…DEA Registration, 87 Fed. Reg. 21,019, 21,020 (Apr. 11, 2022). Applicants will be required to submit all applications through DEA’s secure online portal. The agency has determined that “[r]egulatory changes…
…complainant who, for example, submitted an unreliable or inadequately documented complaint to the Agency, CDRH now has committed to “follow-up communication” and a tracking system. This will allow submitters to…
…Pfizer Inc. and Pfizer Ltd. did not commit inequitable conduct in the prosecution of United States Patent No. 6,469,012; that Teva Pharmaceuticals USA, Inc.’s proposed generic equivalent of Viagra would…
…drug”. We note that a search for “requestor” in the Merriam-Webster dictionary online provided the result “[t]he word you’ve entered isn’t in the dictionary”. Perhaps Congress uses an earlier edition….
…rules under the Executive Order by November 26, 2020, absent a waiver. See M-20-31, Implementation of Section 6 of Executive Order 13924 (Aug. 31, 2020). There is no doubt that…
…years. Registrant errors in completing DEA-222s have been a source of significant civil penalties. This action may alleviate some of these issues. By John A Gilbert & Larry K. Houck…
…Court of Appeals for the D.C. Circuit . . . . We will continue to update you as we learn more information about this interesting case. By Kurt R. Karst…
…custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with Endotec, Inc., and the two individual defendants, Michael J. Pappas, Endotec’s co-owner and president, and…
…Labs., Inc. v. Thompson, 389 F.3d 1272, 1281 (D.C. Cir. 2004), Dobbs v. Wyeth Pharms., 797 F. Supp. 2d 1264, 1270-71 (W.D. Okla. 2011). In ordering FDA to initiate withdrawal…
…from the U.S. Supreme Court’s decision in Telecommunications Research & Action Center v. FCC, 750 F.2d 70 (D.C. Cir. 1984), and that the U.S. Court of Appeals for the District…
…from the D.C. Circuit. Thus, the January 2013 cease and desist order has become effective. Dispositive motions with regard to POM’s D.C. Circuit lawsuit are due on April 25, 2013….
…referred to in court filings as the Composition Patents and the Combination Therapy Patents. Watson (ANDA No. 076798), Mylan (ANDA No. 076801), and presumably Ranbaxy (ANDA No. 076800) submitted ANDAs…