On December 11, 2020, FDA issued the first emergency use authorization (“EUA”) for a vaccine to prevent COVID-19. The vaccine, developed by Pfizer-BioNTech, is authorized for those 16 years of age and older....more
On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....more
U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more
FDA recently revoked a multi-month Emergency Use Authorization (the EUA) for use of chloroquine and hydroxychloroquine as an experimental treatment for patients suffering from COVID-19. ...more
The U.S. Food and Drug Administration has permitted limited use of the antimalarial drugs hydroxychloroquine and chloroquine in the treatment of COVID-19 since issuing an Emergency Use Authorization for such drugs on March...more
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
4/22/2020
/ Biologics ,
Clinical Evaluations ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Product Labels ,
Virus Testing
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
4/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Laboratory Developed Tests ,
Legislative Agendas ,
Proposed Legislation ,
Public Health Service Act ,
Regulatory Oversight
To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020. ...more
Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs