On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
11/25/2020
/ Coronavirus/COVID-19 ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
7/15/2020
/ Coronavirus/COVID-19 ,
Domestic Corporations ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rating System ,
Re-Opening Guidelines ,
Risk Assessment ,
Safety Inspections ,
Tobacco Regulations
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
4/30/2020
/ Civil Monetary Penalty ,
Clinical Laboratory Testing ,
Compliance ,
Coronavirus/COVID-19 ,
Corporate Misconduct ,
Criminal Penalties ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Prosecutors ,
Health IT ,
Inducements ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Off-Label Promotion ,
Patient Safety ,
Pharmaceutical Industry ,
Product Defects ,
Sunshine Act
As health organizations and governments around the world work to contain the coronavirus (COVID-19), businesses should be mindful of the various ways the virus may impact their operations and employees. The wide range of...more
3/5/2020
/ Acquisitions ,
Anti-Discrimination Policies ,
Business Interruption ,
Capital Markets ,
Centers for Disease Control and Prevention (CDC) ,
Commercial Contracts ,
Coronavirus/COVID-19 ,
Corporate Restructuring ,
Cybersecurity ,
Derivatives ,
Disclosure Requirements ,
Employment Policies ,
Equity Securities ,
Force Majeure Clause ,
Global Economy ,
Leveraged Finance ,
Life Sciences ,
Mergers ,
OSHA ,
Popular ,
Public Health ,
Public Safety ,
Publicly-Traded Companies ,
Securities and Exchange Commission (SEC) ,
Securities Litigation ,
Supply Chain ,
Virtual Meetings