On March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more
In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more
9/3/2020
/ CARES Act ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Families First Coronavirus Response Act (FFCRA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Public Health Emergency ,
Uninsured Patients ,
Virus Testing
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
This content was originally published on April 15, 2020. It was last updated as of Friday, May 29, 2020 at 12:40 p.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
This content was originally published on April 15, 2020. It was last updated as of Saturday, May 2, 2020 at 8:00 a.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
5/4/2020
/ Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU Horizontal Safeguard Regulation (HSR) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health and Safety ,
Medical Research ,
Public Health ,
Scientific Research ,
State of Emergency ,
Travel Rule
This content was originally published on April 15, 2020. It was last updated as of Tuesday, April 21, 2020 at 5:00 p.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting...more
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
4/1/2020
/ Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
EU ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Infectious Diseases ,
Medical Research ,
Public Health ,
South Africa ,
UK ,
Workplace Safety
On March 12, President Trump issued a formal Declaration of a National Emergency that authorizes qualifying nonprofit healthcare entities to receive reimbursement under section 502 of the Stafford Act and FEMA’s Public...more
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