FDA Meeting to Discuss Future COVID-19 Boosters
3/21/22 — The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on April 6 to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Read the FDA announcement.
Shortage of Prefilled Saline Flush Syringes
3/21/22 — In recognition of interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes, the FDA sent a letter to healthcare personnel that included recommendations, including conservation strategies, to maintain the quality and safety of patient care. Read the FDA letter.
Celltrion Recalls Dia Trust COVID-19 Ag Rapid Tests
3/17/22 — Celltrion USA is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. Additionally, the tests’ labeling for the affected products includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months. Read the FDA … Continue reading “Celltrion Recalls Dia Trust COVID-19 Ag Rapid Tests”
FDA Warnings Against Sale and Marketing of Unapproved Product Making COVID-19 Claims
3/18/22 — The FDA issued a warning letter to the operator of one website, Ivermectin24h.com for marketing misbranded drugs for treatment of multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. The FDA also issued a warning letter jointly with the Federal Trade … Continue reading “FDA Warnings Against Sale and Marketing of Unapproved Product Making COVID-19 Claims”
FDA Alert: Safe Use of At-Home COVID-19 Tests
3/18/22 — The FDA issued a safety communication reminding people that at-home COVID-19 diagnostic tests should only be used according to manufactures’ instructions, and that tests kits should be kept out of reach of children and pets. The agency has received reports of injuries cause by incorrect use or storage of at-home COVID-19 diagnostic tests. Read … Continue reading “FDA Alert: Safe Use of At-Home COVID-19 Tests”
Leapfrog Offers Alternative Path to Meeting Hand Hygiene Standard
3/14/22 — In response to public comments and feedback, The Leapfrog Group Hospital Survey as announced that it will be offering an alternative path to meeting the organization’s Hand Hygiene Standard. In its March 14 “Summary of Changes to the 2022 Leapfrog Hospital Survey & Responses to Public Comments,” Leapfrog said that the alternative path “requires … Continue reading “Leapfrog Offers Alternative Path to Meeting Hand Hygiene Standard”
FDA/FTC Warning Against Soda Pharm
3/10/22 — The FDA and FTC issued a joint warning letter to Soda Pharm for selling unapproved products with fraudulent COVID-19 claims.
CDC Project Firstline Event for Healthcare Workers March 16
3/15/22 — CDC is hosting a webinar to present Project Firstline’s new infection control education materials. The webinar will be Wednesday, March 16, 1 – 2 PM ET. Presenters will include: Dr. Rochelle Walensky, Director of CDC; Dr. Denise Cardo, Director of CDC’s Division of Healthcare Quality Promotion; and Dr. Mike Bell, Deputy Division Director of CDC’s Division … Continue reading “CDC Project Firstline Event for Healthcare Workers March 16”
COVID-19 Test to Treat Initiative
3/7/22 — The Biden-Harris Administration is launching a new nationwide Test to Treat initiative that will give individuals an important new way to rapidly access free lifesaving treatment for COVID-19. In this program, people will be able to get tested and—if they are positive and treatments are appropriate for them—receive a prescription from a healthcare provider, … Continue reading “COVID-19 Test to Treat Initiative”
FDA Authorizes Shelf Life Extension for Janssen COVID-19 Vaccine
3/11/22 — The FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. This extension applies to all refrigerated vials of the Janssen COVID-19 vaccine that have been held in accordance with the manufacturer’s storage conditions. Read … Continue reading “FDA Authorizes Shelf Life Extension for Janssen COVID-19 Vaccine”