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
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
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