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Updated: Jan 17, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
[Drug safety and mandatory reporting]
Christian Behles1, Robert Hoffmann2, Dennis Lex2
1Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland. christian.behles@bfarm.de.
Abstract:
The spontaneous reporting system for cases of suspected side effects is a central instrument for detecting possible side effects after a pharmaceutical preparation has received marketing authorization. It provides important information (signals) on the occurrence of rare, previously unknown side effects, on increases in the frequency of known side effects that may also be due to quality defects, or on changes in the type or severity of known side effects. In recent decades, this system has made a significant contribution to the identification of drug-related risks that only arise upon widespread use following approval and to the introduction of appropriate measures to minimize risk.
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