Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
9/2/2025
/ Artificial Intelligence ,
Biotechnology ,
Continuing Legal Education ,
Data Privacy ,
Enforcement ,
EU ,
Events ,
Food and Drug Administration (FDA) ,
Health Technology ,
Life Sciences ,
Med Tech ,
Medical Devices ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Privacy Laws ,
Regulatory Requirements ,
Technology Sector
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...more
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
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
4/2/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Class Action ,
Continuing Legal Education ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Events ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare Facilities ,
Healthcare Fraud ,
Labeling ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
PHI ,
Popular ,
Prescription Drugs ,
Product Defects ,
Regulatory Requirements ,
Risk Management ,
State Privacy Laws ,
Sunshine Act
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting.
Are you prepared for a Sunshine Act audit? Reporting...more
2/9/2024
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Reporting Requirements ,
Sunshine Act
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
10/5/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Biotechnology ,
Chief Compliance Officers ,
Compliance ,
Connected Items ,
Consent ,
Continuing Legal Education ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Security ,
Durable Medical Equipment ,
EU ,
Events ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Medical Devices ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Physicians ,
Regulatory Requirements ,
Risk Management
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
4/24/2023
/ Acquisitions ,
Best Practices ,
Biotechnology ,
Chief Compliance Officers ,
Continuing Legal Education ,
Corporate Counsel ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Due Diligence ,
Enforcement Actions ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Mergers ,
Pharmaceutical Industry ,
Third-Party Risk
Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more