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…inapplicable regulatory provision on timing. Then, in its second letter, the agency claimed the clinical-superiority hypothesis was in fact required by virtue of still another regulation, although that rule, too,…
…prevent the plaintiff “from seeking judicial review of FDA’s legal position,” Pl.’s Mot TRO, ECF No. 3, at 4, starting with the FDA denying, without comment on the merits, the…
…FDC Act, under which exclusivity is patent-by-patent, thereby giving rise to the possibility of shared 180-day exclusivity. That is, where there are, for example, two Orange Book-listed patents for a…
…issued on May 18, 2010, is listed with a “U-642” PUC, defined as “TREATMENT AND PREVENTION OF OSTEOPOROSIS,” and the ‘957 patent, which issued on August 12, 2008, is listed…
…expires. According to Pfizer, “[t]o give effect to the Opinion and Final Order,” the court should, consistent with 35 U.S.C. § 271(e)(4)(A), amend its judgment to add that the effective…
…order prohibiting Serra and its co-owners from “receiving, preparing, processing, packing, holding, and distributing all food at or from their facility . . . unless and until” they bring such operations into compliance…
…“Rogue Pain Clinics” & “Pill Mills,” Prescription Drug Awareness Conference, May 4-5, 2013, unnumbered slides. However, if the American Medical Association (“AMA”) adopts either of two committee resolutions at its…
…federal court, the Commission would have been much better off staying “home” in Shire. Instead, the FTC took a strong position before the Third Circuit, arguing that Section 13(b): (1)…
…here), Zogenix first sued Massachusetts Governor Deval Patrick and other Commonwealth officials after the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, took actions to combat…
…to Pacira on September 22, 2014, was formally withdrawn and FDA issued a letter clarifying the reasons for its withdrawal (“Rescission Letter”). Stipulation and Order at 2, Pacira Pharms., Inc….
…The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in…
On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018)….
…compliance” is not dispositive on the issue of whether agency action is final. See, .e.g., FDA Regulatory Procedures Manual, 4-1 (“Warning Letters are issued to achieve voluntary compliance . . ….
…National Drug Control Policy. The report will require feedback from patient groups, pharmacies, drug manufacturers, common and contract carriers, hospitals, state attorneys general, law enforcement, insurance providers, and drug distributors. …
…is worth noting that FDA has authority to order mandatory device recalls and repair, replacement or refunds (and reimbursement of expenses in complying with the order). This authority is set…