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
Regulating CRISPR: FDA and Industry Offer Perspective
By Zachary Brennan -
Published 21 June 2017
Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.
Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics