eCFR :: 21 CFR 600.80 — Postmarketing reporting of adverse experiences. Title 21 —Food and DrugsChapter I —Food and Drug Administration, Department of Health and Human ServicesSubchapter F —BiologicsPart 600 —Biological Products: GeneralSubpart D —Reporting of Adverse ExperiencesSource: 59 FR 54042, Oct. 27, 1994, unless otherwise noted.Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c,…
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Individual Case Safety Reports (ICSRs) Every country has representative who reports Medicines’ side effects to World Health Organizations (WHO). Each side effect related “a drug” (aka Primary Suspect Drug) must be reported to WHO.
FDA’s Adverse Event Reporting System (FAERS) Public Website https://fis.fda.gov/hub/ offers dashboard by Product Report Statistics Demographic Reaction Cases Listings For Vaccines, VAERS click here The Vaccine Adverse Event Reporting System (VAERS) About (cdc.gov)