Search Results for CRISPR

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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

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

BIO Chair: Trump Should Re-Appoint Califf to Head FDA By Zachary Brennan - Published 17 November 2016

In a phone interview with Focus on Thursday, Ron Cohen, MD, president and CEO of Acorda Therapeutics and chair of industry group BIO, offered his views on increasing funding for the US National Institutes of Health (NIH), what the future may hold for the US Food and Drug Administration (FDA), as well as some new ideas and possible solutions to help contain rising drug prices.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Robert Califf, BIO, Acorda Therapeutics, CRISPR

European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016) By Nick Paul Taylor - Published 04 February 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Veterinary products

Tags: database of off-label treatments, UK legislation, pandemic vaccines, CRISPR

Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions By Zachary Brennan - Published 03 February 2016

While the US Food and Drug Administration (FDA) sits on the fence over whether to approve preclinical or clinical trials using mitochondrial replacement techniques (MRT) to help prevent the transmission of certain diseases passed from mother to child, the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine came out with a new report on Wednesday detailing how it believes FDA should allow such trials and regulate them.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: MRT, mitochondrial DNA, inherited diseases, FDA regulation of MRT, CRISPR

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