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…under 13; and Companies that have actual knowledge that they are collecting PI via another company’s website or online service that is directed to children. If a company is covered…
…There were a few presentations that included research and data on how consumers read disclosures online, and the innovative techniques that some companies are creating to effectively communicate disclosures (including…
…The Petition seeks review of a final FDA order published in the Federal Register on April 2, 2018 (the “Order”). The Order denied requests for a hearing and withdrew approval…
…must publish a proposed order in the Federal Register, consider any comments submitted on the proposed order, and hold a device classification panel meeting. After consideration of comments on the…
…issued). It stated that it would “order coercive incarceration if a complete recall [was] not completed.” In August 2014, the Court found that Defendants did not complete the ordered recall. …
…it possesses “competent and reliable scientific evidence” which the Order defines as at least “two adequate and well-controlled human clinical studies” substantiating the representation. The Order specifies that these studies…
…patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin). Heeding the court’s order, the PTO granted the second interim PTE. The long-running dispute over a PTE for the ‘404 patent, which…
…disclosure of material connections, and the FTC guide Dot Com Disclosures: Information About Online Advertising. (The FTC is currently seeking comment on the latter guide to determine whether an update is…
…August 6, 2015 Order dismissing for lack of personal jurisdiction patent infringement litigation timely initiated by Purdue. (We say “appears” because the court’s Order is not expressly characterized as vacating…
…a reclassification regulation, while now FDA can accomplish the same thing by administrative order. The order is to be issued “following publication of a proposed reclassification order in the Federal…
…in court, by seeking a temporary retraining order to block the order from remaining in effect. We expect many companies to request the expedited hearing provided by FSMA. Indeed, we…
…FDA would not be ordered to require egg producers to label commercial eggs as being from “free range” or “cage free” hens, or from “caged hens.” Compassion over Killing v….
…other things, a group of letters sent by the U.S. House of Representatives Energy and Commerce Committee Oversight and Investigations Subcommittee and the U.S. Senate Finance Committee to myriad public…
…Composition Patents and the Combination Therapy Patents, expire in 2016. Watson, and apparently Mylan (ANDA No. 076801) and Ranbaxy (ANDA No. 076800), all submitted ANDAs to FDA on July 15,…
…U-546 listing for PRANDIN within twenty days from the date of the Order and Injunction. Novo promptly appealed the decision to the Federal Circuit, which stayed the district court’s Order…