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2 weeks ago | 
mondaq.com | Kyle Faget |Nathan Beaver |David Rosen |Monica R. Chmielewski
A Texas judge for the U.S. District Court for the EasternDistrict of Texas issued a ruling on March 31, 2025, to vacateand set aside, in its entirety, the U.S. Food and DrugAdministration's (FDA) Final Rule titled Medical Devices; LaboratoryDeveloped Tests (LDTs) (LDT Final Rule).
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1 month ago | 
mondaq.com | Kyle Faget |Nathan Beaver |David Rosen
On March 5, 2025, one U.S. District Court ruled unequivocally inthe Food & Drug Administration's (FDA) favor in the case,Outsourcing Facilities Ass'n, et. al. v. U.S. Food and DrugAdmin., et. al., 4:24-cv-0953-P, slip op., 2025 WL 746028, at*15 (N.D. Tex. Mar.
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1 month ago | 
jdsupra.com | Nathan Beaver |Kyle Faget |Nathaniel Lacktman
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes” in social media advertisements by telehealth companies. The Act would require the U.S. Food & Drug Administration (FDA) to target false and misleading prescription drug promotions by social media influencers and telehealth companies.
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1 month ago | 
jdsupra.com | Nathan Beaver |Kyle Faget |David Rosen
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op., 2025 WL 746028, at *15 (N.D. Tex. Mar.
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Jan 10, 2025 | 
mondaq.com | Madeline Knight |Kyle Faget |Nathan Beaver
FL Foley & Lardner More Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges.
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Jan 9, 2025 | 
mondaq.com | Kyle Faget |Nathan Beaver |David Rosen
On December 4, 2024, the U.S. Food &Drug Administration (FDA) released its Marketing Submissions for aPredetermined Change Control Plan (PCCP) for ArtificialIntelligence-Enabled Device Software Functions (AI-DFS) final guidance document ("PCCPGuidance" or "final guidance"). The final guidancediscusses the scope of applicability of PCCPs, policy behind PCCPs,and the major components necessary to include in submissions forPCCP approval.
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Jan 8, 2025 | 
jdsupra.com | Nathan Beaver |Kyle Faget |Madeline Knight
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance outlines FDA’s enforcement policy on firm-initiated communications of scientific information about unapproved uses of approved or cleared medical products to health care providers...
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Jan 7, 2025 | 
jdsupra.com | Nathan Beaver |Kyle Faget |Sheridan Organ
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final guidance document (“PCCP Guidance” or “final guidance”). The final guidance discusses the scope of applicability of PCCPs, policy behind PCCPs, and the major components necessary to include in submissions for PCCP approval.
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Dec 3, 2024 | 
jdsupra.com | Nathan Beaver |Jessica M. Boubker |Kyle Faget
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product, tirzepatide, be added to FDA’s Demonstrable Difficulties for Compounding (DDC) lists.
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Dec 3, 2024 | 
mondaq.com | Kyle Faget |Nathan Beaver |David Rosen
Brand companies who own GLP-1 products have been pushing the
Food and Drug Administration (FDA) to limit their compounding. On
August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product,
tirzepatide, be added to FDA's Demonstrable Difficulties for
Compounding (DDC) lists.
