| Literature DB >> 30017092 |
Toni Cathomen1, Silke Schüle2, Martina Schüßler-Lenz2, Mohamed Abou-El-Enein3.
Abstract
Medicinal products based on genome editing must undergo rigorous preclinical testing and are subject to regulatory oversight for proper risk assessment prior to first evaluation in humans. We give a European perspective on the regulatory expectations to translate genome editing to the clinic to ensure their timely progress to market.Entities:
Keywords: CRISPR; clinical trials; commercialization; ethics; genome editing; regulation
Mesh:
Year: 2018 PMID: 30017092 DOI: 10.1016/j.tibtech.2018.06.005
Source DB: PubMed Journal: Trends Biotechnol ISSN: 0167-7799 Impact factor: 19.536