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2 weeks ago | 
packagingdigest.com | David Rosen |Nathan Beaver |Kyle Faget |Sheridan Organ
tadamichi via Getty ImagesOn January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The draft guidance is designed to coordinate with and complement recently issued final guidance on predetermined change control plans for AI-enabled devices.
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2 weeks ago | 
mondaq.com | David Rosen |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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3 weeks ago | 
jdsupra.com | Nathan Beaver |Kyle Faget |David Rosen
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially unfair and deceptive conduct relating to compounded GLP-1 medications.
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1 month ago | 
mddionline.com | David Rosen |Nathan Beaver |Kyle Faget |Sheridan Organ
On Jan. 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The draft guidance is designed to coordinate with and complement recently issued final guidance on predetermined change control plans for AI-enabled devices.
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2 months 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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Mar 19, 2025 | 
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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Mar 17, 2025 | 
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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Mar 13, 2025 | 
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.
