Mark Gardner

Managing Partner - Gardner Law, Adjunct Professor - University of Minnesota Law School, Adjunct Professor of Law - Mitchell Hamline School of Law, Senior Lectur

[Gardner Law @GardnerPllc]

Gardner Law Expands Services with Litigation Focus:

We're thrilled to announce the launch of our new litigation practice. Led by industry veteran David Graham. Learn more about our expanded capabilities: https://t.co/QpRZMw6Vhh. #litigation #medicaldevice #food #drug

[Gardner Law @GardnerPllc]

News: Drug and biologic submissions that include Real-World Evidence (RWE) meeting specific criteria will now be aggregated. Understand the new reporting criteria and what it means for your company's use of real-world data here: https://t.co/4HNkDQAPIL

[Gardner Law @GardnerPllc]

This Thursday, we'll discuss the dos and don’ts of providing information to the government, how to protect your company and its employees, and ways to minimize the burden on your company in our Government Investigations webinar series.

Register now: https://t.co/qDE0tkHapj

[Gardner Law @GardnerPllc]

Breaking news! The United States Supreme Court ended the 40-year-old Chevron doctrine which directed federal courts to give deference to administrative agencies’ reasonable interpretations of ambiguous federal statutes. Read this alert for details: https://t.co/3dnzTsVEwU

[Gardner Law @GardnerPllc]

This alert summarizes key takeaways from Paul Rothermel's recent presentation, 10 Things You Should Know About Privacy, Consent, and HIPAA. Organizations must implement robust privacy practices to protect personal data and avoid significant penalties

https://t.co/qKGm7PkAUF

[Gardner Law @GardnerPllc]

@GardnerPllc's Amanda Johnston recently presented "Compliance Considerations in High-Tech Healthcare" at a CLE program. Check out this summary of her session re: the convergence between #healthcaretech and #compliance. https://t.co/u1HQY5gcYY

[Gardner Law @GardnerPllc]

In this alert, we highlight three significant #litigationtrends that have emerged over the last year. The disregard and assessment of current doctrines, as well as the targeting of over-the-counter medications are key focuses in 2024. https://t.co/B38SYVSJB9

[Gardner Law @GardnerPllc]

Gardner Law attend MedTech MVP 2024 this week in Minneapolis. It was great to connect with all of the presenters and attendees about regulatory and privacy considerations for connected devices, including those utilizing AI. #medtech

[Gardner Law @GardnerPllc]

Beginning this week: Government Investigations Webinar Series - Are you prepared to respond if the government requests information from your company or its employees? Learn how in this series. View sessions and register here: https://t.co/qDE0tkHapj

[Gardner Law @GardnerPllc]

Navigating the complex legal and regulatory landscape of the medical device industry is more crucial than ever. Our latest article breaks down avoiding costly missteps, mitigating risk, and more: https://t.co/qqR4Rc6guq

[Gardner Law @GardnerPllc]

The #DOJ had a record year, and we reviewed FCA enforcement actions to identify trends to help you stay informed and proactive in your compliance efforts. This alert summarizes key takeaways from our recent presentation on DOJ and FCA enforcement trends: https://t.co/Vv1YS1U983

[Gardner Law @GardnerPllc]

Read this alert to find out key insights for #FCSmanufacturers and suppliers and why it is critical to promptly review any FCN-related notices you receive from the FDA. https://t.co/yPAdZDdJqE

[Gardner Law @GardnerPllc]

#FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Find out the details of the draft guidance, how it can streamline the approval process for manufacturers, and how Gardner Law can help: https://t.co/uDSOg0FX0N

[Gardner Law @GardnerPllc]

Understanding your regulatory maturity will go a long way in successfully bringing a medical product to market in the U.S. Discover 5 high-level considerations that should be assessed throughout the life-cycle of your #medicalproduct here: https://t.co/vCYDJMIZCO

[Gardner Law @GardnerPllc]

The FDA published a report that could reshape the future of AI in medicine. Get ahead of the curve by influencing the rules, unlocking innovation, and staying compliant. Read our newest alert to find out more about what this means to our industry: https://t.co/6odmI08aeI #AI #FDA

[Mark Gardner @markegardner]

@ThaddeusPope Congrats, Thad!

[Mark Gardner @markegardner]

I'm moderating a panel discussion, "FDA Regulatory, Compliance, and Privacy Due Diligence—Finding Your Goldilocks Zone," tomorrow at the MedTech MVP conference in Minneapolis w/ James Eadie, Sarah Karlgaard, and Ryan Egeland. Hope to see you there!

[Mark Gardner @markegardner]

Paul Rothermel, JD, CIPM provides the scoop on new Washington privacy law impacting drug and device makers. See below. #privacy #law https://t.co/lvQMwpj0qa

[Mark Gardner @markegardner]

Tomorrow I'm kicking off the 2023 Minnesota CLE Health Law Institute meeting with Caitlyn Francois and Heidi Christianson. We're covering a range of topics from #CMS to #FDA to #OIG updates. Hope to see you there! Agenda: https://t.co/PMMGBhb3a3
#law #he…https://t.co/dbXbJKgVqH

[Mark Gardner @markegardner]

"An insurer’s letter was sent directly to a newborn child denying coverage for his fourth day in a neonatal intensive care unit. 'You are drinking from a bottle,' the denial notification said, and 'you are breathing on your own.' I…https://t.co/w4lWloVnPU https://t.co/jwW0LV1Kgf