Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 38

The United States reporting requirements for spontaneous reporting are found in 21CFR314.80. Serious, unlabeled (US Package Insert), spontaneous, and literature events, whether felt to be causally related or not, must be reported within 15 calendar days (plus day 0) when the four minimum validity criteria are met. Reports from FDA, either from the MedWatch to Manufacturer Program or FOI, do not have to be sent to FDA but may need to be sent to other HAs.