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On Friday, President Biden issued a wide ranging Executive Order seeking to address overconcentration, monopolization, and unfair competition in the U.S. economy. Using an aptly named “whole-of-government” approach, the Order…
…(Triangle). FDA issued this order based on its finding that several Triangle products contained kratom that tested positive for salmonella. FDA issued the order after the company failed to respond…
Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones…
By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”)…
…appropriate only when there is a scientific and/or medical dispute related to a final order. A proposed order or an interim order is not an appropriate subject for an FDR….
…five Commissioners questioning the two-RCT substantiation requirement in recent FTC consent orders, suggests that we may well see fewer two RCT orders in the future. This decision is unlikely to…
…and the court granted, a Motion for Clarification, Amendment, or Reconsideration of Order raising certain jurisdictional issues. FDA promptly filed a Motion to Dismiss – and a Proposed Order – arguing…
…on file from Gilead with respect to each ORDER TO SHOW CAUSE letter. And Gilead takes the PTO to town(!): As described below, Applicant believes that the Order rests on…
…process, has “stringent standards” against the issuance of prescriptions based on online consultations, and does not certify Canadian online pharmacies. Google also hired a third-party company to detect pharmacy advertisers’…
…results of the November election. The three executive orders and the possible fourth are described below. Executive Order on Importation of Drugs One Executive Order directs HHS to complete its…
Earlier this week, President Biden signed Executive Order 14081, titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” The Executive Order was spurred in part…
By Jennifer M. Thomas – President Obama issued an Executive Order earlier this week to address the growing issue of critical drug shortages – the first Executive Order to directly…
…of the order, FDA defines PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an IV [Iodine Value] greater than…
…order. FDA must grant meeting within 45 days after date of meeting Adcom: FDA may convene advisory committee (adcom). Final Order: 90 days after closing of comment period, if sufficient…
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) held a press conference in Chicago to announce a lawsuit against several companies, including Central Coast Nutraceuticals, iLife, Simply…