FDA Roundup Feb. 2022
Today, the U.S. Food and Drug Administration offer a brief overview of the latest news from the agency:
- The FDA published a brand new resource, At-Home COVID-19 Diagnostic Tests. This resource includes a complete list of FDA-approved at-home, over-the-counter (OTC) COVID-19 tests. Tests and other protection measures such as wearing a mask and getting a COVID-19 vaccine are vital in stopping co-infection with COVID-19. Home-based OTC COVID-19 tests for diagnosis play an essential part in fighting COVID-19.
- On February. 18th The FDA has approved an expansion of Medtronic’s Freezor and Freezor Xtra Cardiac Cryoablation Catheters to include children 2 years old or older. This approval extends the need for cryoablation for atrioventricular Reentrant Tachycardia (AVNRT), an illness that causes an abnormally fast heartbeat. These episodes typically begin and end abruptly. In a minimally-invasive surgical procedure, the device utilizes very cold air to permanently freeze and remove a tiny part of the heart responsible for the unusually rapid heartbeat. The approval also adds cryothermal mapping capability with the Freezor Xtra catheter. Cryothermal mapping allows the cardiac surgeon to identify the area that needs treatment before permanently destroying the tissue.
- On February. 18 on Feb. 18, the FDA advised the general public that various FDA-regulated items were purchased between Januarys. 1st, 2021 to the present, at Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri, and Tennessee could be dangerous for consumers. The affected products were sourced from the company’s distribution center located in West Memphis, Arkansas. An FDA inspection discovered unsanitary conditions that included a rodent population that could contaminate many of the items to be infected. The FDA cooperated with the company to unintentionally recall the affected items.
- On February. 15, in the FDA’s efforts to protect users, FDA sent warning letters to the operators of two websites: Extrapharmacy.ru and Rxshopmd.com, for marketing unapproved and misbranded medications for multiple illnesses such as COVID-19. Drugs that bypass the regulatory protections could be infected with counterfeit ingredients, have varying quantities of active ingredients or have different ingredients. Consumers can go to the website BeSafeRx to learn more about the safest way to purchase medicine on the internet. Anyone concerned about COVID-19 needs to talk to their healthcare doctor.
- On February. 11, as part of the FDA’s efforts to protect its consumers from harm, they sent a cautionary letter at CytoDyn Inc. for making claims in a marketing situation that the leronlimab drug, which is a medication that is not approved or approved by the FDA and is therefore efficient and safe to the treatment of COVID-19. Anyone concerned about COVID-19 needs to seek advice from their healthcare physician.
- COVID-19 test Updates:
-
- Today present time, 420 tests, as well as devices for collecting samples, are approved through FDA with emergency approvals (EUAs). This includes 290 molecular tests along with sample collection instruments, 85 antibodies, and other tests of the immune response, as well as 45 tests for antigen. There are 70 authorizations for molecular tests and one antibody authorization that may be used for home-collected samples. There is a EUA for molecular-based prescription tests at home, three EUAs for prescription antigen at-home tests, fifteen EUAs for antigen over-the-counter (OTC) tests at home, and three EUAs for molecular OTC tests at-home.
- The FDA has approved 26 antigen tests and 10 molecular tests in the serial screening program. The FDA has also granted 843 changes of EUA authorizations.
