Policy Updates

4/26/22 — The FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients ages 28 days and older with positive results of direct SARS-CoV-2 viral testing, who are hospitalized, or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19. This makes Veklury the first approved COVID-19 treatment for children … Continued

4/21/22 — The CDC issued a Health Alert Network (HAN) Health Advisory to notify clinicians and public health authorities of a cluster of children identified with hepatitis and adenovirus infection at a large children’s hospital in Alabama. Nine children have been admitted to that hospital with hepatitis and adenovirus infection between October 2021 and February 2022. … Continued

4/20/22 — HHS Secretary Xavier Becerra has renewed the COVID-19 public health emergency (PHE) through July 15, 2022. Read the HHS ASPR announcement.

4/13/22 — The FDA authorized a shelf-life extension for the two presentations of the Tris/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine, supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border. The authorization allows the frozen vials to be … Continued

4/14/22 — The FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. This is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The test is authorized for people ages 18 and older without symptoms. It must be performed by a qualified, trained … Continued

4/19/22 — As a result of a court order, effective as of April 18, 2022, CDC’s January 29, 2021 Order requiring masks on public transportation conveyances and at transportation hubs is no longer in effect. Therefore, CDC will not enforce the Order. CDC continues to recommend that people wear masks in indoor public transportation settings at … Continued

4/8/22 — The FDA issued a warning letter jointly with the Federal Trade Commission to Sensory Cloud, Inc for selling unapproved products with unproven COVID-19 claims.

4/8/22 — The FDA authorized two over-the-counter (OTC) at-home COVID-19 antigen tests. The validation data was gathered through the FDA’s collaboration with the National Institutes of Health (NIH) and the Independent Test Assessment Program (ITAP). The emergency use authorizations (EUA) issued to Osang LLC was for their OHC COVID-19 Antigen Self-Test and Xiamen Boson Biotech Co., Ltd for … Continued

4/8/22 — The FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to nine months. This extension was granted following a thorough review of data submitted by Janssen. … Continued