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Policy Updates

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FDA Expands EUA for Monoclonal Antibody Treatment to Children
01/06/2022
FDA Expands EUA for Monoclonal Antibody Treatment to Children

12/3/21 — The FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who … Continued

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FDA Authorizes 3 OTC COVID-19 Tests
01/06/2022
FDA Authorizes 3 OTC COVID-19 Tests

11/23/21 — The FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age 2 years or older when an adult collects the nasal swab sample. These tests are: InBios SCoV-2 Ag Detect Rapid Self-Test delivers results in about 20 minutes. The … Continued

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