news updates, December 4: What to know today about COVID-19 in the Seattle area, Washington state and the world
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- As part of the FDA’s effort to protect consumers, the agency issued a jointly with the Federal Trade Commission to Rat’s Army for selling unapproved products with fraudulent COVID-19 claims. The company sells “VIRUS BIOSHIELD” with misleading claims that the product can mitigate, prevent, treat, diagnose or cure COVID-19 in people. Consumers concerned about COVID-19 should consult with their health care provider.
- On Dec. 2, the FDA updated the comparative data on our website to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2.The FDA provided the panel, comprised of standardized samples, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their emergency use authorization (EUA).
- Testing update:
- As of Dec. 1, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.Today, the FDA issued a guidance, ” This guidance provides the FDA’s enforcement policy regarding certain requirements for mammography facilities and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency.
- On Dec. 3, the agency issued an Emergency Use Authorization (EUA) for the the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic. The system, manufactured by 3B Medical Inc., is a Tier 3 system intended for bioburden reduction (or reduction of microorganisms) of 3M Model 1860 N95 respirators only, and only for single-user reuse, as a supplement to the Centers for Disease Control and Prevention (CDC) Tier 3 bioburden reduction systems are intended to be used in addition to and not in lieu of CDC reuse recommendations. In evaluating the EUA request, the FDA reviewed available scientific evidence, including scientific literature, performance testing, and other information related to bioburden reduction and the use and reuse of filtering facepiece respirators as described in the
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https://www.torontolofts.ca/jss/d-c.html - The FDA has added content to the question-and-answer appendix in its guidance titled, ” The updated guidance includes a new question and answer regarding considerations for disposing unused investigational drug product when a study participant cannot return it to the study site. The guidance addresses considerations for using alternative procedures for the disposition of the investigational product provided that such procedures do not expose humans to risks from the drug.
- The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors. The challenge is open now through January 29, 2021.
- Testing updates:
- As of Dec. 1, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.