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…lawsuit dropped. Spectrum Pharmaceuticals, Inc. (“Spectrum”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction challenging FDA’s February 24, 2015 denial of a Citizen Petition (Docket…
…If a party fails to comply with a 6(b) order after receiving a notice of default from the Commission, the Commission may commence suit in federal court under Section 10…
…the listed drug.” Second, “the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative,” just the patent number and…
…of initial disclosures,” or the company “withheld documents from the federal government during its investigation.” The court concluded that it was “much more palatable to believe Boston Scientific committed a…
…how this will work. At a minimum, under the statute, FDA has authority to issue a classification order in response to an accessory classification request. We assume this order will…
…collaboration” about the Drug Enforcement Administration’s (“DEA’s”) efforts to combat prescription drug abuse. While voicing strong support of DEA’s efforts to fight prescription drug abuse, the letter states that recently…
…order is not required, however, if a manufacturer submits a report under section 905(j) of the Act for the new tobacco product (a “905(j) report”) and FDA issues an order…
By Riëtte van Laack – The Court of Appeals for the Eleventh Circuit overturned a contempt order against Hi-Tech, Jared Wheat, Stephen Smith, and Dr. Terrill Mark Wright (“Hi-Tech”) because,…
…the company met the requirement for granting exclusivity by using FDA’s Formal Dispute Resolution process. As we previously reported, Amgen alleges in the company’s Complaint and Motion for Temporary Restraining…
…before it is commercially marketed; and (5) the PMA is the first permitted commercial use of the product. With respect to the timely filing requirement, the statue, at 35 U.S.C….
DEA’s administrative docket is off to a quiet start this year. Since January, the Administrator has issued five final orders, all of which are so-called “loss of state authority” cases….
…an opinion granting summary decision in favor of Complaint Counsel, FTC staff, against California Naturel. The Final Order bars the Company from misrepresenting its products as all natural. The facts…
…drug product containing new and old actives, the NCE component must have been approved first, followed by the combination drug. In that case, NCE exclusivity granted with respect to the…
…RCTs even more doggedly in Consent Order negotiations and litigated orders, and/or (2) revise its substantiation guidance to explicitly require “Laine-Level” substantiation as “competent and reliable evidence” for certain categories…
…disproportionately affects poor and marginalized populations.” (Emphasis added.) In its final order, the Agency also affirmed its commitment to using “a flexible approach” to tropical disease designations based on “scientifically…