Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 20

EMA uses this phrase for an SAR in a clinical trial that is serious, listed (i.e., expected) in the reference safety information, e.g., investigator brochure, and suspected to be due to the drug in question. See the definitions for serious and expected. The FDA does not define this phrase in 21CFR312.32(a) or use this phrase formally for cases, though application of the concept is similar and relevant.