Today, the FDA posted FAQs on Testing for Monkeypox with answers to frequently asked questions relating to the development and performance of tests for monkeypox. to include myocarditis and pericarditis and also issued a draft guidance that provides recommendations on risk-based computer software assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system as well as provided COVID-19 testing updates.
Today, the FDA reissued the letter of authorization for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc.
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