What's New

FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
2020-9-18
The FDA has published comparative performance data to show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. Read more.
CDC Updates COVID-19 Testing Guidance
2020-9-18
The CDC has revised COVID-19 testing guidance to clarify that asymptomatic individuals who have had close contact with someone who is COVID-19-positive needs to be tested for the virus. Read the updated CDC guidance.
Evidence-Based Recommendations to Protect Infants from S. Aureus

CDC released new recommendations for the prevention and control of Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA) and methicillin-sensitive S. aureus (MSSA), in infants in neonatal intensive care units (NICUs). The guideline makes specific recommendations about interventions to implement in NICUs when there is:
FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

The Food and Drug Administration (FDA) published comparative performance data for more than 55 COVID-19 molecular diagnostic tests that used an Emergency Use Authorization (EUA). According to the FDA, the published data shows a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. However, the data does not indicate how sensitive a particular test is, and should not be used by itself to determine whether to authorize a test or other regulatory action. The FDA is hoping this new data provides laboratories, healthcare providers, and patients a new resource on the performance of available tests to better inform their testing decisions. Learn more.
FDA Issues Warning Against COVID-19 Websites

The FDA issued warning letters to operators of two websites, www.extrapharma.com and www.medication-house.com, that market unapproved COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19.
ASPR TRACIE LTC COVID-19 Toolkit

The HHS Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) has developed a toolkit to provide COVID-19 assistance to nursing homes, skilled nursing facilities, and assisted living facilities. Read the ASPR TRACIE COVID-19 Considerations for Long-Term Care Facilities.
ASPR TRACIE Webinar Series -- Hidden Consequences: How the COVID Pandemic is Impacting Children

The HHS Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) and Pediatric Centers of Excellence are collaborating on a webinar series focused on the impact of the COVID-19 pandemic on children. This one-page summary includes more information and registration links for each webinar.
Maintaining Healthcare Safety during the COVID-19 Pandemic: Brief Presentations

As a follow up to the ASPR TRACIE webinar Ensuring Healthcare Safety throughout the COVID-19 Pandemic on June 2, the agency partnered with the COVID-19 Healthcare Resilience Working Group and the Agency for Healthcare Research and Quality (AHRQ) on a series of short presentations featuring healthcare professionals sharing their experiences as they worked through the operational realities of maintaining and prioritizing healthcare safety during COVID-19. This summary document includes links to each presentation.
FDA/FTC Warning Against Vital Care Compounder Selling Fraudulent COVID-19 Products

The FDA issued a warning letter jointly with the Federal Trade Commission to Pharmacy Plus, Inc. dba Vital Care Compounder for selling unapproved products with fraudulent COVID-19 claims. The company sells “COVID PACK” and “COVID ‘POSITIVE’ PACK” products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that the company immediately stop selling these unapproved and unauthorized products.
FDA Webinar on Gowns and Apparel for HCP During COVID

On Tuesday, September 15, 12:00 p.m.-1:00 p.m. ET, the FDA will host a webinar to review these topics:

Coronavirus Facts

With coronavirus disease (COVID-19) at the forefront of the news and lawmakers minds, now is an important time to help educate your state lawmakers about the virus.
Act Now to Secure PPE: Every Minute Matters

Healthcare workers are not being provided the PPE they need for the COVID-19 pandemic. According to a recent APIC survey, nearly half of U.S. healthcare facilities are already out of, or almost out of respirators. Contact your Members of Congress today!
Act Now to Secure PPE: Every Minute Matters (Administration)

Healthcare workers are not being provided the PPE they need for the COVID-19 pandemic. According to a recent APIC survey, nearly half of U.S. healthcare facilities are already out of, or almost out of respirators. Contact the President today!
Support Transparent and Accurate Data Reporting

Urge your Members of Congress to continue working with the Centers for Disease Control and Prevention (CDC) and NHSN data collection efforts to combat COVID-19.