 FDA reissues EUA for certain imported disposable filtering facepiece respirators FDA reissued the EUA for imported, non-NIOSH-approved, disposable filtering facepiece respirators (FFRs) manufactured in countries other than China. The FDA revised and reissued this EUA to authorize for emergency use only those respirators listed in the EUA's Exhibit 1 as of the date of this reissuance. Effective immediately, the FDA will no longer be reviewing requests and adding new respirator models to Exhibit 1 of this EUA. (March 24, 2021) Update on COVID-19 variants and impact on bamlanivimab distribution (HHS) Given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, will stop the distribution of bamlanivimab alone starting March 24, 2021. FDA recently updated the authorized Fact Sheet for Healthcare Providers (PDF) for the bamlanivimab EUA. This update advised healthcare providers to consider the use of alternative authorized monoclonal antibody therapies that are expected to retain activity against circulating viral variants. Using an alternative authorized monoclonal antibody therapy may reduce the risk of treatment failure should a patient be infected with a SARS-CoV-2 viral variant that is resistant to bamlanivimab alone. Alternative monoclonal antibody therapies that are currently authorized for the same use include bamlanivimab and etesevimab administered together and REGEN-COV. Read more (March 24, 2021) Serology EUA template update for test developers FDA posted an updated template with recommendations on what to include in EUA requests or Pre-EUA submissions for SARS-CoV-2 serology tests with home specimen collection. The FDA updated the Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot to add clarity throughout and provide updated recommendations for pre-collection stability. This template is intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used. (March 25, 2021) Updated in vitro diagnostics EUA web section FDA's Center for Devices and Radiological Health (CDRH) reorganized the SARS-CoV-2 In Vitro Diagnostics EUAs content on FDA.gov to help make it easier to find specific categories of EUAs and related information. With this update, new web pages have been created for these EUA types: Diagnostic test EUAs As of today, 349 tests and sample collection devices are authorized by FDA under EUAs. These include 258 molecular tests and sample collection devices, 74 antibody and other immune response tests, and 17 antigen tests. There are 42 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test. Also see: Coronavirus Testing Basics | 
No comments:
Post a Comment