Articles
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1 day 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 week 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On Jan. 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The draft guidance is designed to coordinate with and complement recently issued final guidance on predetermined change control plans for AI-enabled devices.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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2 months 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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2 months 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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