ICH ------------------------------------------------------------------------------------------------------- ICH Page
VAERS (Vaccine Adverse Event Reporting System) ------------------------------------------------------------------------------------------------------- VAERS (Vaccine Adverse Event Reporting System)
ADVERSE EVENT REGULATIONS RELATED TO DRUG SAFETY ------------------------------------------------------------------------------------------------------- 21 CFR 310.305 - Records & reports of adverse drug experiences on marketed drugs (no approved NDA) 21 CFR 312.32 -- IND Safety Reports 21 CFR 314.80 -- Postmarketing reporting of adverse drug experiences. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.