Resolving Gene Editing Technology's Ethical and Regulatory Challenges
By Vidya Narayanaswami, PhD, Dr. Stephen F. Amato -
Published 13 December 2017
This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges.
Categories: Features, FDA, Biologics and biotechnology, Ethics
Tags: Gene Editing, Gene Therapy, CRISPR, Cas9
Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate
By Michael Mezher -
Published 14 November 2017
At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries.
Categories: News, US, FDA, Biologics and biotechnology, Clinical, Ethics
Tags: Gene Editing, Gene Therapy, CRISPR, CRISPR-Cas9, Editas
Human Gene Editing, CRISPR and FDA: How Will They Mix?
By Zachary Brennan -
Published 02 December 2015
A number of the world’s top scientists, policy experts and bio-ethicists met this week in Washington, DC to discuss the implications of human gene editing, and though the focus of the summit was centered more on ethical considerations than regulations, opinions flew on Wednesday over how some new technologies will likely be regulated.
Categories: News, Asia, Canada, Europe, US, FDA, Biologics and biotechnology, Combination products, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Medical Devices
Tags: gene editing, FDA, CRISPR, gene editing regulations, harmonized regulations