The FDA Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session on October 22, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. The meeting time is 10 am – 5 pm ET. No specific application will be discussed at … Continue reading “FDA Panel to Meet to Discuss COVID-19 Vaccine”
The FDA issued a warning letter jointly with the Federal Trade Commission (FTC) to For Our Vets LLC dba Patriot Supreme for selling unapproved products with fraudulent COVID-19 claims. The company sells CBD products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
CDC’s National Healthcare Safety Network (NHSN) released a new Point of Care (POC) Laboratory Reporting Pathway within the NHSN LTC COVID-19 Module on October 15. The new Pathway will enable CMS-certified nursing homes, and other long-term care facilities, to meet the Department of Health and Human Services’ requirement to report SARS-CoV-2 point-of-care antigen test data, … Continue reading “It’s Here: New NHSN Pathway for LTC Lab Reporting of COVID-19”
FDA Revises Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
The FDA reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institute for Occupational Safety and Health (NIOSH). Under the earlier version of this EUA, a respirator was authorized if it met certain eligibility criteria. According to the October 15, 2020 reissued EUA, … Continue reading “FDA Revises Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China”
A federal task force has released the updated National Action Plan on Combating Antibiotic-Resistant Bacteria (CARB) for 2020-2025. The National Action Plan presents coordinated, strategic actions that the U.S. Government will take in the next five years to improve the health and wellbeing of Americans by changing the course of antibiotic resistance. This Plan is … Continue reading “New CARB National Action Plan Released”
The FDA announced the revocations of the Emergency Use Authorizations (EUAs) issued to Autobio Diagnostics Co. Ltd. for the Anti-SARS-CoV–2 Rapid Test and to Manufacturers and Other Stakeholders for certain in vitro diagnostic SARS-CoV–2 Antibody Tests. The EUA for the Autobio test was revoked because further studies have demonstrated poor performance for the device. The … Continue reading “FDA Revokes EUAs for Autobio and Other SARS-CoV-2 Diagnostic Tests”
The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19-related products. The companies, Griffo Botanicals and Prairie Dawn Herbs, offer herbal products for sale in the United States with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
CMS updated COVID-19 public reporting tip sheets for Skilled Nursing Facilities (SNFs) and Long-Term Care Hospitals (LTCHs). The tip sheets include strategies for data exempted from public reporting and the impact on the Nursing Home Compare website refresh.
The FDA recommends that healthcare providers give clear, step-by-step instructions to patients who, in a healthcare setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test. Read the FDA recommendations.
The FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for reporting a process for notifying FDA about adverse events for the Battelle Critical Care Decontamination System. The Battelle decontamination system is authorized under an FDA emergency use authorization (EUA) for use in decontaminating certain N95 respirators for … Continue reading “FDA Issues Warning to Battelle About Respirator Decontamination System”