Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the FDA…
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/ Administrative Law, Health, International Law & Trade
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early signs…
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/ Administrative Law, Health, Science, Computers, & Technology
FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree…
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/ Administrative Law, Communications & Media Law, Health
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and it’s…
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/ Administrative Law, Health, Science, Computers, & Technology
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important…
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/ Administrative Law, Commercial Law & Contracts, Consumer Protection, Health
On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to World-Changing…
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/ Privacy, Health, Science, Computers, & Technology
In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static…
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/ Administrative Law, Business Organizations, Health
Every document your employees create—emails, text messages, meeting notes, voicemails—has the potential to become critical evidence in litigation. In today’s legal environment, even casual communications can expose your company…
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/ Business Organizations, Civil Procedure, Electronic Discovery
In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program…
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/ Administrative Law, Health, Privacy
A HIPAA compliance assessment is an evaluation of an organization's practices, policies, and procedures to ensure that they align with requirements from the Health Insurance Portability and Accountability Act (“HIPAA”). It…
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/ Administrative Law, Health, Privacy
Celebrity Endorsements -
As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms…
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/ Administrative Law, Communications & Media Law, Health
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is…
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/ Administrative Law, Consumer Protection
The Evolving Role of AI/ML in Healthcare -
The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,…
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/ Health, Intellectual Property, Science, Computers, & Technology
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the…
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/ Administrative Law, Labor & Employment Law, Health, Science, Computers, & Technology
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant financial…
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/ Administrative Law, Consumer Protection, Health, Products Liability
