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…Importer that will buy the drug directly from the Foreign Seller. The Foreign Seller must be licensed by Health Canada as drug wholesalers and registered with FDA as a Foreign…
…filed a Complaint and Motions for a Temporary Restraining Order and Preliminary Injunction against FDA in the U.S. District Court for the District of Columbia “to vindicate their statutory rights”…
…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…
…PLAN B One-Step) available Over-the-Counter (“OTC”) and without point-of-sale or age restrictions (see our previous post here). (Judge Korman recently clarified that the 30-day deadline for compliance with his order…
…any approved methods of using the listed drug” (emphasis added). Second, “the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use…
…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…
…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…
…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….
…satisfy the statutory and regulatory criteria falls squarely on the SIP Sponsors. The government also pointed out that Canada’s Minister of Health has issued an interim order that prohibits would-be…
…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…
…that were previously prescription medications,” and that “BTC [drugs] could be comprised of certain medications available behind the counter at the pharmacy without a prescription and require the intervention of…
…it did eventually issue proposed rules establishing OTC hearing aids in October 2021, after President Biden issued an Executive Order in July 2021 commanding publication. The Comment Period for those…
…one of administrative orders. Instead of rulemaking which would take six or more years, FDA expects that the administrative orders process can be completed in less than two years. Moreover,…
…(see our blog post here), the regulated community has been eager to engage with FDA to understand both the procedural and substantive requirements for submitting an OTC monograph order request…