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  • Agency Deficiencies Focus of Newly Proposed Scientific Subcommittee

    The US Food and Drug Administration's (FDA) Science Board will consider a motion to establish a new subcommittee at an October 2012 meeting that will seek to revisit some of the problems raised in a landmark 2007 report about scientific deficiencies at FDA. That report, FDA Science and Mission at Risk (2007), was prepared by the Science Board's Subcommittee on Science and Technology, and leveled three charges against FDA: Its scientific base is weak and eroding...
  • Feature ArticlesFeature Articles

    Tarantulas: Possible Lifesavers?

    • 07 August 2012
    In the past, I have written about many creatures in the animal kingdom, and several of them were on the top of the most hated and feared list. Rats, spiders and snakes are prime examples. My earlier article about spiders described how spider webs could be used to fashion artificial ligaments or tendons. 1 Tarantulas, another arachnid in that species, may prove valuable in treating a number of pathologies. This article will describe them, their venom, mechanisms of acti...
  • Sport Products Focus of MHRA, Academic Investigations

    It hasn't been a particularly good week food and supplement manufacturers, and in particular those of the sport science variety. In a widely-covered study published in the British Medical Journal, lead-author Carl Heneghan and ten of his colleagues set about trying to determine what evidence, if any, substantiated claims by sports drink manufacturers that their products enhanced athletic performance. The results were not flattering for the manufacturers of the 104 p...
  • Feature ArticlesFeature Articles

    Lister and Semmelweis - Two Misunderstood Geniuses

    • 17 July 2012
    In a recent The New England Journal of Medicine review of the past 200 years of surgery, author Atul Gawande, MD, MPH, mentioned that Joseph Lister's seminal work on antisepsis was regarded with overwhelming skepticism by the medical profession. 1 This was despite the fact Lister's work was heralded in a series of articles he wrote for The Lancet . However, this same journal found the alleged breakthrough as a method neither original nor beneficial. 2 Ignac Semmelw...
  • Proposed Legislation Would Require FDA to Develop Guidelines to Ensure Scientific Quality

    A bill proposed in late June 2012 by a bipartisan group of congressmen would require all federal agencies, including the US Food and Drug Administration (FDA), to develop guidelines to ensure "scientific information relied upon by the agency" meets a number of quality standards. The bill, H.R. 5952 - To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the ...
  • Feature ArticlesFeature Articles

    Pythons—A Model to Study Human Heart Disease?

    • 15 June 2012
    Many of my previous articles for RAPS have featured a host of disparate animals that are or could be used in medicine or in medical research, including leeches, maggots, rats, spiders, whipworms, Gila monsters and zebrafish. Now, there is new evidence to include Burmese pythons on this distinguished list. This snake species may be used to develop drugs to treat human heart disease. 1 In anticipation of this event, it would be prudent to know more about  Burmese pyth...
  • Government Looks to Regulatory Science to Reduce Dependence on Animals in Preclinical Testing

    • 13 June 2012
    The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies. In a report released for public comment in May 2012, DHHS, working with more than a dozen other federal agencies known as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), said better methods are needed to assess the benefits and...
  • CBER Releases Strategic Plan for 2012-2016 Period

    The US Food and Drug Administration's (FDA) biologics regulatory body, the Center for Biologics Research and Evaluation, has released its strategic regulatory plan for the upcoming five years. The plan, " Strategic Plan for Regulatory Science and Research ," was released 10 May 2012 and explores how the center plans to "provide the environment to facilitate the development of new biological products and evaluate them for safety and effectiveness." CBER's plan outlines s...
  • NIH Launches New Program to Share Drug Compounds

    • 04 May 2012
    The National Institutes of Health's (NIH) new National Center for Advancing Translational Sciences (NCATS) said it will launch a new pilot program to partner with a number of pharmaceutical manufacturers in an effort to look for new uses for some of their existing compounds. NCATS, currently under the temporary leadership of Thomas Insel , was formed in late 2011 to spur the development of new therapies by focusing on ways to bridge the so-called "valley of death" betwe...
  • FDA's Chief Scientist Reveals Planned Animal Rule Revisions, Regulatory Science Initiatives

    US Food and Drug Administration's (FDA) Chief Scientist Jesse Goodman gave a presentation to FDA's Science Board on 2 May, laying out a number of upcoming FDA activities and priorities including the agency's planned revision of its Animal Rule draft guidance and a number of new regulatory science initiatives. Goodman noted FDA has selected three projects from a pool of 35 applicants for its regulatory science Challenge Grant program. The three projects aim to create biom...
  • Hamburg Touts FDA's Promotion of a 'Robust Field of Regulatory Science' in Speech

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg touted her agency's efforts to advance and promote a 'robust field of regulatory science' in a speech before a NEHI Conference. Calling regulatory science "important," Hamburg laid out some of what FDA has managed to accomplish in the last few years, including the establishment of three Centers of Excellence in Regulatory Science, working to get the Reagan-Udall Foundation up and running and the format...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...