The US Food and Drug Administration (FDA) has maintained its status as a resource of advice and action for pharmaceutical, clinical trial and life sciences professionals as the virus rages on around the globe. Read on to learn more about the agency's latests moves related to the COVID-19 pandemic.
The agency has issued a number of emergency use authorizations (EUAs) around testing for the virus. One is an EUA reissued for LabCorp’s COVID-19 RT-PCR test, including two new indications for use:
- Testing patients without any symptoms
- Permitting pooled sample testing.
The FDA also issued EUAs for Two molecular diagnostic tests for qualitative detection of SARS-CoV-2. One was issued to Eli Lilly for its SARS-CoV-2 assay; the other was to Sandia national Laboratories, for the SNL-NM 2019 nCoV RT-PCR diagnostic assay.
Offsite test guidance
The FDA posted a new template designed to help companies develop and submit EUA requests for offsite diagnostic tests. The EUAs would cover tests allowed to be performed at home, offices, schools and other non-medical settings, without a prescription.
Details covered in the template include recommendations for validation when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis. The resource also outlines the recommended performance for this type of test, including sensitivity and specificity.
Responses to date
The agency issued another update to its updated FDA COVID-19 Response At-A-Glance Summary document. The resource includes facts, figures and key components of FDA response efforts.
The FDA and Federal Trade Commission (FTC) continue to scour the market for products falsely claiming to prevent, treat or cure the virus; to date, no such products have been okayed by the FDA. The latest companies to receive a warning letter: 21st Century LaserMed Pain and Regenerative Medicine Institute.