viernes, 11 de septiembre de 2020

Coronavirus (COVID-19) Update: Daily Roundup September 10, 2020 | FDA

Coronavirus (COVID-19) Update: Daily Roundup September 10, 2020 | FDA

US Food and Drug Administration

Coronavirus (COVID-19) Update: Daily Roundup September 10, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Pharmacy Plus, Inc. dba Vital Care Compounder for selling unapproved products with fraudulent COVID-19 claims. The company sells “COVID PACK” and “COVID ‘POSITIVE’ PACK” products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Pharmacy Plus, Inc. dba Vital Care Compounder immediately stop selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
    • As of today, 247 tests are authorized by FDA under EUAs; these include 197 molecular tests, 46 antibody tests, and 4 antigen tests.

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