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…tool for some companies with orphan drug designations. The case namesake of the “Depomed Threat” is Depomed, Inc. v. HHS, — F. Supp. 2d –, 2014 WL 4457225 (D.D.C. Sept….
…any legally marketed device to a patient for any condition or disease . . . .” 21 U.S.C. § 396. Petitioners also argued that the ban violated the Administrative Procedure…
…a 30-month stay on the approval of NDA 208090. See Purdue Pharma LP et al. v. Colleaium Pharmaceutical Inc., Case 1:15-cv-00260 (D. Del. Mar. 24, 2015); Purdue Pharma L.P. et…
By Kurt R. Karst – Queue up the dueling banjo scene from the film Deliverance. . . . Early last month we saw an interesting press release from Veloxis Pharmaceuticals,…
…now terms the “bulks”) is occurring during FDA’s Pharmacy Compounding Advisory Committee (PCAC) (Oct. 26 and 27). This is the third PCAC meeting this year, at which the PCAC has…
…See United States v. Park, 421 U.S. 648 (1975); United States v. Dotterweich, 320 U.S. 277 (1943). Of particular interest, the District Court noted that the DeCosters: created a work…
…bring cases against individuals. She anticipated that DOJ would revise the U.S. Attorney’s Manual (USAM) to implement these principles. On November 16, 2015, again via a speech by Ms. Yates,…
…your Regulatory Project Manager for additional or more detailed information. . . . It is not feasible for us to respond to a high volume of follow up inquiries.” …
…person in the United States at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry….
…review standards.” While these initial numbers are encouraging, it is understandable if industry remains cautious. It is a bit too soon to consider these results to be “trends.” Though some…
…of that. You have to be thoughtful, creative, timely, and, above all, committed (both the dedicated and “strait-jacket” meanings of the word apply). A successful blog also requires teamwork. And…
…and Product Jurisdiction: Time for Reforms,” Hyman, Phelps & McNamara, P.C., Director Jeffrey N. Gibbs discusses the FDA jurisdictional process and some of its challenges. Reminder: Register now for the May…
…2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, and 12 years and about 10 months after the MMA’s enactment, we finally have new Hatch-Waxman regulations. On…
…for a single food agency have bubbled up over the years, and the impending election makes now a good time to reconsider the issue. Hyman, Phelps & McNamara, P.C.’s Ricardo…
…requires thoughtfulness, creativity, timeliness, dedication, and teamwork. These are all attributes of the team at Hyman, Phelps & McNamara, P.C. REMINDER: You can follow FDA Law Blog on Twitter @fdalawblog….