As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
12/14/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Data Integrity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry
Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence
Last month the Department of Education (“DOE” or “Department”) released an...more
11/23/2020
/ Accounting Controls ,
Audits ,
Compliance ,
Department of Defense (DOD) ,
Department of Education ,
Department of Energy (DOE) ,
Department of Justice (DOJ) ,
Educational Institutions ,
False Claims Act (FCA) ,
FBI ,
Foreign Entities ,
Higher Education Act ,
NASA ,
National Institute of Health (NIH) ,
National Security ,
Proposed Legislation ,
Reporting Requirements
The Department of Justice (DOJ) recently announced that it reached a $5,500,000 settlement with a biomedical research institute that received NIH grant funding–the Van Andel Research Institute (VARI)–to resolve allegations...more
2/26/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure To Disclose ,
False Claims Act (FCA) ,
Federal Grants ,
Foreign Investment ,
Government Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Research Funding ,
Settlement