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[4], three firms that sell unapproved and misbranded products with fraudulent COVID-19 Coronavirus claims, and iThrive.Health [5], a firm that promotes and participates in the sale of such products. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider. On December 11th, the agency approved an abbreviated new drug application for midazolam injection [6], indicated for preoperative sedation/anxiolysis (anxiety)/amnesia; as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures; for induction of general anesthesia; and as a continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. ....
December 14, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible. As part of the FDA’s effort to protect consumers, the agency issued warning letters jointly with the Federal Trade Commission to Indigenous Products, Heavenly Natural Products and Health & Wellness Center International One, L.L.C. dba Hotze Vitamins, three firms that sell unapproved and misbranded products with fraudulent COVID-19 claims, and iThrive.Health, a firm that promotes and participates in the sale of such products. Consumers concerned about COVID-19 should consult with their ....