lunes, 30 de julio de 2018

The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage? - PubMed - NCBI

The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage? - PubMed - NCBI



 2018 Jul 12. pii: S0167-7799(18)30169-0. doi: 10.1016/j.tibtech.2018.06.005. [Epub ahead of print]

The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?

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.

KEYWORDS:

CRISPR; clinical trials; commercialization; ethics; genome editing; regulation

PMID:
 
30017092
 
DOI:
 
10.1016/j.tibtech.2018.06.005

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