…FY 2022, at 13-18, https://www.fda.gov/media/167825/download?attachment. [14] FDA, 510(k) Premarket Notification Search Database (last updated Nov. 13, 2023), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Searches were done for all IVD panels: immunology, microbiology, clinical chemistry, pathology,…

…submitted to FDA and Health Canada within 6 months of acceptance of the pilot program: For FDA, specify if it is a 510(k), De Novo, or pre-market approval (PMA) original,…

…Horton’s from Canada. On February 28, 2017, Senators Bernie Sanders, Cory Booker, and Bob Casey introduced S. 469, the “Affordable and Safe Prescription Drug Importation Act.” (A companion bill was…

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…

…Canada (the “Final Rule”). The Final Rule became effective on November 30, but the potential for Canadian drug importation faces significant challenges. First, on November 23, 2020, Pharmaceutical Research and…

…enforcement. In general, food companies engaged in online marketing that is directed to children, or likely to appeal to children, are at the greatest risk. COPPA governs companies’ collection, use,…

…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’…

…the Dot Com Disclosures since May 2011.  According to Mary Engle (Associate Director, FTC Division of Advertising Practices), the FTC is accepting written comments on the issue through July 11,…

…President Trump’s April 15 Executive Order (EO), “Lowering Drug Prices by Once Again Putting Americans First. That EO provided that within 90 days, “the Secretary, through the Commissioner of Food…

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…

…as opposed to Active Pharmaceutical Ingredients) from Canada, by traveling to Canada and purchasing drugs in pharmacies there, or by mail order, either through Internet websites or through telephone purchases. …

…the SIPs, including controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, intrathecally or intraocularly injected drugs, and drugs subject to Risk Evaluation and Management Strategies…

…would provide savings to commercial health insurance customers. For 17 prescription drugs, VAHS determined that importation from Canada could result in annual savings between $1 and $5 million. However, VAHS…

On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the…

…of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021….