The FDA issued final guidance to provide recommendations to healthcare providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection and describes FDA’s interim compliance and enforcement policy regarding the Investigational New Drug (IND) requirements for the use … Continue reading “FDA Issues Final Guidance on COVID-19 Convalescent Plasma”
The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to: Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset … Continue reading “FDA Updates EUA for Abbott ID Now COVID-19 Test”
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.
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: Evidence of ongoing S. aureus transmission An increased … Continue reading “Evidence-Based Recommendations to Protect Infants from S. Aureus”
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 … Continue reading “FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests”
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.
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.
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 … Continue reading “Maintaining Healthcare Safety during the COVID-19 Pandemic: Brief Presentations”
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 … Continue reading “FDA/FTC Warning Against Vital Care Compounder Selling Fraudulent COVID-19 Products”
As a result of COVID-19 the FDA has issued numerous Emergency Use Authorizations (EUAs) for medical devices intended to diagnose, prevent, or treat COVID-19. In addition, the FDA has issued several COVID-19-related guidance documents intended to help increase the availability and capability of certain types of medical devices used during the COVID-19 pandemic. Read the FDA FAQs.