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…U.S. companies globally and advocate for intellectual property rights that provide certainty for America’s innovative companies in the biosciences and other sectors. . . . In the course of the…
…See Jeff Shuren & William Maisel, Looking Ahead to 2022 as FDA’s Center for Devices and Radiological Health Manages a Sustained Increase in Workload, FDA Voices (Dec. 21, 2021), https://www.fda.gov/news-events/fda-voices/looking-ahead-2022-fdas-center-devices-and-radiological-health-manages-sustained-increase-workload….
…Decision and Order, 89 Fed. Reg. 50,372, 50,377 (June 13, 2024). The Coconut Grove decision introduces no new red flags, but further clarifies DEA’s expectations, especially in the context of…
…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…
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…
…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…
…contend that FDA is “constructively suppressing” claims through the “imposition of an onerous, value laden set of qualifications that only allow Plaintiffs to propound a false, negatively value-laden, and inaccurate…
…be masquerading promotional material as “disease-state” information via websites with unbranded web addresses. Companies, therefore, should be wary of registering websites for any third parties with which they would like…
…in the Act, please contact: Michelle L. Butler, mbutler@hpm.com, 202-737-7551 Alan M. Kirschenbaum, akirschenbaum@hpm.com, 202-737-4283 Jeffrey N. Wasserstein, jwasserstein@hpm.com, 202-737-9627 David C, Gibbons, dgibbons@hpm.com, 202-737-4286 Serra J. Schlanger, sschlanger@hpm.com, 202-737-4593…
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…Letter of Medical Necessity as required by the Board of Registration in Pharmacy that includes the patient’s diagnoses and treatment plan, verifies that other pain management treatments have failed, indicates…
…said he reads numerous responses to FDA Forms 483, the report that FDA issues at the end of a GMP inspection, and that it is critically important that the responses…
…trigger its 180-day exclusivity (which might not happen through commercial marketing because of the company’s manufacturing problems), and for which Ranbaxy qualified as a result of the company’s Paragraph IV…