Gardner Law

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423 Main Street South
Stillwater, MN 55082, United States
Phone: (651) 430-7150
Areas Of Practice
  • Health
  • Privacy
Locations
Other U.S. Locations
  • Minnesota
Number of Attorneys
11-24 Attorneys

What to Do When FDA Detains Your Shipment

When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice of…more
 /  Administrative Law, Health, International Law & Trade

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into device…more
 /  Administrative Law, Health, Science, Computers, & Technology

New DOJ Rule Restricts Deidentified Data Transfer

No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer - This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized, and…more
 /  Health, International Law & Trade, Privacy

The Importance of a Clinical Trial Strategy

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions…more
 /  Health, Science, Computers, & Technology

Staying Prepared Amid FDA Changes

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…more
 /  Administrative Law, Health, International Law & Trade

Are FDA Review Timelines Slipping? What Companies Need to Know

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…more
 /  Administrative Law, Health, Science, Computers, & Technology

FDA’s Latest Untitled Letter: An Enforcement Tell?

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…more
 /  Administrative Law, Communications & Media Law, Health

FDA Goes All In on AI: What It Means for Your Submissions

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…more
 /  Administrative Law, Health, Science, Computers, & Technology

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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…more
 /  Administrative Law, Commercial Law & Contracts, Consumer Protection, Health

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

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…more
 /  Privacy, Health, Science, Computers, & Technology

From Paper to Practice: Compliance Policies that Work

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…more
 /  Administrative Law, Business Organizations, Health

What's on File Could Be on Trial - Mastering Documentation Risk

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…more
 /  Business Organizations, Civil Procedure, Electronic Discovery

Why Compliance Audits Are Non-Negotiable

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…more
 /  Administrative Law, Health, Privacy

Recent Enforcement Reminds Companies: Assess HIPAA Compliance

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…more
 /  Administrative Law, Health, Privacy

Exercise Caution: Celebrity Endorsements of Medical Products

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…more
 /  Administrative Law, Communications & Media Law, Health
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