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
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 January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more
2/23/2024
/ Annual Reports ,
Center for Drug Evaluation and Research (CDER) ,
Drug Compounding ,
DSCSA ,
Enforcement ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Noncompliance ,
Quality Control Plan ,
Supply Chain ,
Written Descriptions
Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...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
When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more
8/8/2023
/ Anti-Kickback Statute ,
Audits ,
Buyers ,
CMP Law ,
Compliance ,
Due Diligence ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Policies and Procedures ,
Privacy Laws ,
Regulatory Requirements ,
Sellers ,
Stark Law ,
Sunshine Act
Are you licensed to sell in these states?
Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more
7/20/2023
/ Distributors ,
Filing Requirements ,
Healthcare ,
Licenses ,
Manufacturers ,
Marketing ,
Registration Requirement ,
Regulatory Requirements ,
Sellers ,
State and Local Government ,
State Legislatures
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
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
12/2/2022
/ Clinical Trials ,
Compliance ,
Continuing Legal Education ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Documentation ,
Draft Guidance ,
EU ,
European Data Protection Board (EDPB) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Individual Accountability ,
International Data Transfers ,
Labeling ,
Manufacturers ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Park Doctrine ,
Popular ,
Public Health ,
Regulatory Violations ,
Reporting Requirements ,
Risk Management ,
Schrems I & Schrems II ,
SCOTUS ,
Separation ,
Standard Contractual Clauses ,
Transparency
Here are key points made by the all general counsel panel on various topics.
Key Points: Physician remunerative relationships, OIG Special Fraud Alert on Speaker Programs, & Virtual Interactions...more
10/20/2022
/ AdvaMed ,
Anticompetitive Behavior ,
Cybersecurity ,
Data Privacy ,
EU ,
Food and Drug Administration (FDA) ,
Fraud Alerts ,
Insurance Industry ,
Medical Device Reports (MDRs) ,
OIG ,
PHRMA ,
Premiums ,
Remuneration ,
Speaker Programs ,
Virtual Meetings
Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more
9/29/2022
/ AdvaMed ,
Anti-Fraud Provisions ,
Anti-Kickback Statute ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Enforcement ,
Ethics ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Government Investigations ,
Healthcare Workers ,
Hospitals ,
Internal Communications ,
Open Payments ,
Settlement ,
Speaker Programs ,
Supremacy Clause ,
Transparency ,
Value-Based Care