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…company believes should have supported FDA fully granting the company’s petition. Finally, Sanofi alleges that FDA has also dismissed, “without any rational justification or analysis, a wealth of scientific evidence…
…in the patient’s damaged joint in order to repair it (“Regenexx Procedure”). Regenerative Sciences, Inc. v. FDA, United States District Court for the District of Columbia, June 22, 2010 (“Complaint”). …
…are arranged according to review areas, such as administrative information, 510(k) summary, performance data, engineering performance, biocompatibility, sterilization, software validation, clinical data, and labeling. An AI letter typically begins with…
…settlement agreements. According to the FTC, “[o]ne of the Commission’s top priorities is putting an end to anticompetitive pay-for-delay patent settlement agreements.” Indeed, the Commission commented in its January 2010…
…18, 2000 and the PTE application would have been timely filed within 35 U.S.C. § 156(d)(1), rather than on Friday, December 15, 2000 when FDA issued its approval letter (at…
…qui tam actions. See e.g., United States ex rel. Rost v. Pfizer, Inc., 446 F.Supp. 6 (D. Mass 2006), a ruling later affirmed by the U.S. Court of Appeals for…
…sought. . . .” Teva’s Complaint requested declaratory and injunctive relief. Shortly after the March 2, 2010 decision was issued, Teva filed an Emergency Motion To Issue Mandate Forthwith, because…
…21, 2004) and Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F. Supp.2d 104, 109 (D. Mass. 1998), Matrix argued that: [A]bsent a stay, Defendants are in a Catch-22 situation…
…with the use of the drug are discovered.” 44 Fed. Reg. 37434, 37447 (June 26, 1979); see also CDER, Manual of Policies and Procedures (MAPP) 6020.10, NDAs: “Dear Health Care…
…civil contempt proceedings against Mr. Trudeau, arguing that he had violated a 2004 Consent Order’s command that he not misrepresent the content of his book. FTC v. Trudeau, No. 08-4249,…
…of promotional activity, including package inserts, pamphlets, mailing pieces, fax bulletins, reprints of press releases, and all other literature that supplements, explains, or is otherwise textually related to the product.”…
…order to meet this designation, Standard 2, Resolution of Personal Conflicts of Interest of the ACCME Standards for Commercial SupportSM would be fulfilled by recusal. That is, no person who…
…statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to amend their complaint to comply with the Court’s recent ruling in Wyeth v. Levine. The…
By Jeffrey N. Wasserstein & William T. Koustas – On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial…
…advancing the effective date to January 1, 2019. However, on November 2, 2018, the Court issued an order declining to stay the case, reasoning that HHS cannot guarantee that the…