Nathan Beaver

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Articles

FDA Outlines AI Medical Device Software Recommendations in Draft Guidance

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tadamichi via Getty ImagesOn January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The draft guidance is designed to coordinate with and complement recently issued final guidance on predetermined change control plans for AI-enabled devices.
GLP-1 Compounded Medications Targeted By Connecticut Attorney General

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.
Nathan A. Beaver

2 weeks ago | packagingdigest.com | Nathan Beaver |David Rosen

About Your PrivacyWe process your data to deliver content or advertisements and measure the delivery of such content or advertisements to extract insights about our website. We share this information with our partners on the basis of consent and legitimate interest. You may exercise your right to consent or object to a legitimate interest, based on a specific purpose below or at a partner level in the link under each purpose.
David L. Rosen

2 weeks ago | packagingdigest.com | David Rosen |Nathan Beaver

About Your PrivacyWe process your data to deliver content or advertisements and measure the delivery of such content or advertisements to extract insights about our website. We share this information with our partners on the basis of consent and legitimate interest. You may exercise your right to consent or object to a legitimate interest, based on a specific purpose below or at a partner level in the link under each purpose.
GLP-1 Compounded Medications Targeted by Connecticut Attorney General | JD Supra

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.
FDA Outlines AI Medical Device Software Recommendations in Draft Guidance

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.
Nathan A. Beaver

1 month ago | mddionline.com | Nathan Beaver |David Rosen

MD+DI Online is part of the Informa Markets Division of Informa PLCThis site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Texas Court Vacates FDA's Laboratory Developed Test (LDT) Final Rule

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).
Compounded GLP-1 Drugs: Texas Judge Denies PI Motion And Request For Stay Of FDA's Declaration That Tirzepatide Shortage Is Resolved; Plaintiff OFA Appeals

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.
Telehealth Companies and Social Media Influencers May Face New FDA Laws | JD Supra

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.