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…2020, DEA announced a “proactive collaboration with online e-commerce companies” to inform and educate e-commerce companies about the requirements and importance of safeguarding these products and ensuring they do not…
The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. The Ryan Haight Act was…
…the meeting in person, while others may join the meeting online; others may be entirely online. However, to the best of our knowledge, CDRH has not granted a meeting where…
…products. If you have questions or need more information, contact: Jeffrey K. Shapiro, jshapiro@hpm.com, 202-737-9633 Jeffrey N. Gibbs, jgibbs@hpm.com, 202-737-4288 Jennifer D. Newberger, jnewberger@hpm.com, 202-737-4292 Allyson B. Mullen, amullen@hpm.com, 202-737-9639…
…whether supply chain disruptions are leading to specific bottlenecks, shortages, anti-competitive practices, or contributing to rising consumer prices.” The recent section 6(b) orders were sent to Walmart Inc., Amazon.com, Inc.,…
…differences.) We welcome comments on this blog post by email to jshapiro@hpm.com. If a critical mass of comments is received, we will publish a round‑up, including our responses and potential…
…dismisses the administrative complaint, an appeals court overturns the injunction, or the Commission issues a final order. Notably, this same company received a WL from FDA and FTC in November…
…agency within DOJ, it seems extraordinary that DEA would have issued a policy statement on marijuana only to have DOJ then determine that the policy failed to comply with the…
…§ 45a does not extend to online and mail order claims as that provision refers to product labels, not to other labeling or advertising. Comments may be submitted until 60…
…use code as the ‘937 patent), but not a certification to the patent. Novartis followed up its Complaint with a Motion for a Temporary Restraining Order and Preliminary Injunction (“TRO/PI”). …
…seeking an order to immediately stop defendants from handling and dispensing controls. The District Court denied the Government’s motion for a preliminary injunction because it failed to comply with the…
…The amended order limits the court’s previous order to the failure-to-market forfeiture provision at FDC Act § 505(j)(5)(D)(i)(VI) and notes that FDC Act § 505(j)(5)(D)(i)(VI) “was not raised in [Teva’s] Complaint,…
…complied with all of the applicable requirements under the Executive order and have determined that the preemptive effects of this rule are consistent with Executive Order 13132. In another turn…
…deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist; (2) Is…
…drug, listed in descending order based on the percentage of the number of active ingredients in the final dosage form manufactured in such countries; and (2) The identity…