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  • Feature ArticlesFeature Articles

    Resolving Gene Editing Technology's Ethical and Regulatory Challenges

    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. Introduction Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology is a genetic "editing" tool aimed at altering DNA sequences and modifying gene function. It offers promising opportunities for ...
  • Regulatory NewsRegulatory News

    Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate

    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. Specifically, the hearing focused on CRISPR/Cas9, which is a gene editing tool that scientists can use to quickly and accurately edit DNA in a variety of applications. While there are curr...
  • Regulatory NewsRegulatory News

    Regulating CRISPR: FDA and Industry Offer Perspective

    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. What is CRISPR? According to the Broad Institute , CRISPR (pronounced "crisper") stands for Clustered Regularly Interspaced Short Palindromic Repeats, which form the basis for a genome ...
  • Regulatory NewsRegulatory News

    BIO Chair: Trump Should Re-Appoint Califf to Head FDA

    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. NIH and FDA For NIH, Cohen echoed sentiments circulating on Capitol Hill around the 21s...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
  • Regulatory NewsRegulatory News

    Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

    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. Background ...
  • Regulatory NewsRegulatory News

    Human Gene Editing, CRISPR and FDA: How Will They Mix?

    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. Background As Jennifer Doudna, a molecular and cell biologist at University of California, Berkeley, and a leader in the field notes in a...