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…the company’s Motion for a Temporary Restraining Order and Preliminary Injunction is under seal, so there’s not a lot for us to go on. The Complaint does reference, however, a…
By Jennifer D. Newberger – On January 31, 2012, Rep. Edward Markey (D-MA) introduced H.R. 3847, the “Safety of Untested and New Devices Act of 2012,” also known as the…
…treat various medical conditions. The intervenor prescriber asserted that, as a consequence of his patient population, he prescribes more scheduled substances than typical doctors. Nevertheless, DEA had interviewed and investigated…
…exclusivity], Amgen shall respond to the reconsideration decision by July 3, 2017; and FDA shall issue a decision on dispute resolution by August 2, 2017,” says the Order. If FDA,…
…tobacco product with the predicate tobacco product with respect to all product characteristics. These include design features (components, subcomponents, specifications, etc.), a listing of ingredients (ingredient names, common names, the…
…has filed over the past few years, including Docket Nos. FDA-2008-P-0529, FDA-2009-P-0555, FDA-2010-P-0642, FDA-2012-P-0555, FDA-2013-P-0025. In each instance (except for one petition that was apparently withdrawn – FDA-2013-P-1128), FDA has…
…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…
…Scientific Corp., 11-cv-02453, Dkt. No. 313 (D. Minn. Oct. 16, 2019). In this “disaster” of a case, Judge Rau sanctioned Defendant Boston Scientific Corporation (BSC) for failing to disclose a…
…pursuant to an Order issued under 35 U.S.C. § 271(e)(4), permanently enjoined from “engaging in the commercial manufacture, use, offer to sell or sale within the United States, or importation…
…Chief Counsel for Foods (2003-2005). Before joining FDA, Mr. Schwartz was a commercial litigator in Washington, D.C., and prior to that, in his native Montreal, Canada. He has law degrees…
…is completed. Product class-specific guidance documents must include criteria for determining biosimilarity, interchangeability, and immunogenicity (if available). In addition, companies may not submit a biogeneric application until the later of…
…safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses that sell consumer products—including food, cosmetics, and OTC drugs—notify Californians about possible…
…Report appear in its Appendices. As anyone who works in the compounding world knows, understanding positions of various states on issues such as sterile and non-sterile compounding, inspections, state licensing…
…authorities, such as the EPA and the European Commission, which had concluded that glyphosate is not likely to be carcinogenic in humans. In fact, IARC was the only entity that…
…food or dietary supplement . . . as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless a Federal court in a final order following a trial…