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
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements -
In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
Liability exposure and shields for vaccine developers -
As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more
5/28/2020
/ Center for Biologics Evaluation and Research (CBER) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
Popular ,
Professional Liability ,
Vaccinations ,
Virus Testing ,
World Health Organization
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials -
Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more
3/4/2020
/ Article III ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Rule 12(b)(1) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Motion for Summary Judgment ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Preamble ,
Public Health Service Act ,
Retroactive Application ,
Rules of Appellate Procedure ,
Standard of Review ,
Standing
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