Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more
9/1/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Long Term Care Facilities ,
Medicare ,
Physicians ,
Reporting Requirements ,
Urgent Care Facilities ,
Virus Testing
On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
8/5/2020
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Physicians ,
Policy Updates ,
Public Health Service (PHS) ,
Reporting Requirements ,
Universities
On March 19, 2020, the Federal Emergency Management Agency (FEMA) issued a Fact Sheet providing additional guidance on emergency protective measures that may be eligible for funding under the Stafford Act when incurred by a...more
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more
3/12/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Educational Institutions ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
National Institute of Health (NIH) ,
Policies and Procedures ,
Scientific Research ,
Universities
As novel coronavirus disease (COVID-19) outbreaks spread across the globe and the number of confirmed cases in the United States rise, healthcare providers nationwide are in the process of preparing for a potential...more