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…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’…
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…
…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…
…and here for our blog posts). In 2018, the Organization for Competitive Markets and the American Grassfed Association requested that FSIS revise its policy on “Product of USA” claims so…
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…
…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…
…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…
…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…
…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….
…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. …
…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…
…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…
…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…
…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…