 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: - On Dec. 21, the FDA published the webpage: Wastewater Surveillance for SARS-CoV-2 Variants describing how the FDA has developed the capacity to sequence SARS-CoV-2 RNA from wastewater samples, which is useful for detecting and monitoring SARS-CoV-2 at the population scale. Monitoring for both known and unknown variants of the virus can provide information about the evolution of the virus, which is critical to evaluating the effectiveness of FDA-regulated COVID-19 vaccines, therapeutics and diagnostics.
- On Dec. 28, the FDA approved an abbreviated new drug application (ANDA 214531) for Albuterol Sulfate Inhalation Solution, 0.63 mg (base)/3 mL and 1.25 mg (base)/3 mL unit-dose vials for the relief of bronchospasm (narrowing of the airways) in patients 2 to 12 years of age with asthma. Side effects of albuterol sulfate inhalation solution include asthma exacerbation, otitis media (middle ear infection), chest pain, and bronchitis. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
- On Dec. 29, the FDA implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant. Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible.
The FDA will continue conducting mission-critical foreign inspections and will reassess plans as needed based on its monitoring foreign travel conditions. The agency also is postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022. The FDA is also continuing to conduct mission-critical domestic inspections. State inspections under FDA contract have the discretion to make inspection decisions based on their local information. Importantly, the agency is continuing remote foreign supplier verification program activities for human and animal foods, as well as leveraging other remote tools to maintain oversight of foods, drugs, medical products and tobacco. - As part of the FDA's effort to protect consumers, the agency issued warning letters to two companies for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider. The companies that received warning letters are:
- Today, the FDA is announcing that it has found an additional three lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but the FDA understands that these AstraZeneca lots, or vaccine made from the lots, may now be exported for use. The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency.
- COVID-19 testing updates:
- On Dec. 27, the FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information. The update removed the Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test from the list of "Tests Expected to Fail to Detect the SARS-CoV-2 Omicron Variant" and added information about the resolution of this issue. On December 22, 2021, the FDA reissued the Tide Laboratories DTPM COVID-19 RT-PCR Test emergency use authorization. The test has been modified and is now expected to detect the SARS-CoV-2 omicron variant.
- On Dec. 27, the FDA authorized an over-the-counter (OTC) COVID-19 antigen test, the first test where validation data were gathered through the FDA's collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The emergency use authorization of the SD Biosensor, Inc. COVID-19 At-Home Test is another example of the FDA's commitment to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating access to these tests for all Americans.
- On Dec. 29, the FDA authorized an additional over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA's collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The emergency use authorization (EUA) of Siemens' CLINITEST Rapid COVID-19 Antigen Self-Test is another example of the FDA's commitment to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating access to these tests for all Americans. This follows the recent authorization of the SD Biosensor, Inc. COVID-19 At-Home Test, distributed by Roche Diagnostics, which was also evaluated through the NIH ITAP.
- As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 43 antigen tests. There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 747 revisions to EUA authorizations.
|
No comments:
Post a Comment