In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more
8/20/2024
/ Acquisitions ,
Continuing Legal Education ,
Cybersecurity ,
Data Breach ,
Department of Justice (DOJ) ,
Due Diligence ,
Events ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Loper Bright Enterprises v Raimondo ,
Mergers ,
Safe Harbors ,
Statutory Interpretation
...It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient. Understanding...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
In December 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices. While the guidance is currently in draft form...more
Nathan Downing presented on artificial intelligence in medical products and strategies for partnering with FDA at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California. If you do not...more
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
While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create...more
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
After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more
7/11/2022
/ Advertising ,
Clinical Trials ,
Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs