Carol Taccetta, MD: Boxed Warning, the FDA’s Most Prominent Warning, Absent from All COVID-19 Vaccine Fact Sheets Despite Criteria Being Met
Introduction There are some adverse reactions in a product label that are so serious, and possibly even preventable, that special labeling is required to highlight this warning information: a “BOXED WARNING.” https://www.fda.gov/media/71866/download https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57 This boxed warning information, “critical for a prescriber to consider,” is commonly referred to as a “black box.” (https://www.fda.gov/media/71866/download) Boxed Warnings […]
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