• Regulatory NewsRegulatory News

    FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices

    The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. Background Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped...
  • Regulatory NewsRegulatory News

    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
  • Regulatory NewsRegulatory News

    On the Heels of FDA Investments, PhRMA Funds Regulatory Science Initiative

    In recent years, the US Food and Drug Administration (FDA) has made substantial investments in regulatory science initiatives, spending millions on research, establishing new academic programs, and partnering with dozens of institutions in the pursuit of new ways to bring safe and effective drugs to market more quickly. But the agency isn't the only one interested in advancing regulatory science. In an announcement this week, the influential pharmaceutical industr...
  • Regulatory NewsRegulatory News

    FDA Plans to Spend as Much as $50M on Regulatory Science, With Focus on Generics

    The US Food and Drug Administration (FDA) has released its latest " Broad Agency Announcement " detailing the areas to which it hopes to direct funding in the coming year in order to solve or alleviate some of its most pressing regulatory needs. Like FDA's 2013 Broad Agency Announcement, the 2014 announcement says FDA is prepared to spend—"subject to congressional appropriations"—as much as $50 million on meeting nine overarching goals and dozens of sub-level interests. ...
  • Feature ArticlesFeature Articles

    Sleep—Still a Mystery!

    • 07 May 2014
    Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains. Sleep remains one of the secrets of science. 1 However, there is ample evidence indicating that difficulty in falling asleep and non-restorative sleep are associated with the risk of cardiovascular disease in adults and young children. Statistically, after adjusting for lifestyle factors, age and chronic conditions, researchers ...
  • Two New Centers of Regulatory Science Excellence Launched by FDA

    The US Food and Drug Administration (FDA) is throwing its support behind two new scientific programs intended to advance the state of regulatory science in the US. Under an agreement announced on 5 May 2014, Johns Hopkins University and the University of California at San Francisco/Stanford University will join two other universities working with FDA as "Centers of Excellence in Regulatory Science and Innovation" (CERSI). The programs are part of an effort by FDA to bri...
  • Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine

    New legislation introduced in the House of Representatives this week seeks to develop a comprehensive framework capable of allowing the "rapid approval" of regenerative medicine products by the US Food and Drug Administration (FDA). While the bill, the Regenerative Medicine Promotion Act (RMPA) of 2014 , does not define the term "Regenerative medicine," it is defined by the National Institutes of Health as, "the process of creating living, functional tissues to repair...
  • Feature ArticlesFeature Articles

    A Case for Quality from an Industry Perspective

    The US Food and Drug Administration (FDA) recently has asked whether it has been using the right methods to improve device quality. To answer that question, the agency has developed and embarked on a plan to reduce the number of recalls related to failed devices. The problem, according to FDA, lies in the fact that, in the past, there was more focus on compliance than on quality. Based on this account, it could be argued that FDA knows more about quality than industry or ...
  • FDA 's Marketing Pitch to Scientists: Come Work for Us

    Good regulation depends on good science, and good science-while it can come from serendipity or accidents-usually comes from good scientists. The classic question for regulators at the US Food and Drug Administration (FDA), then, has been how to recruit those scientists to the agency and then retain them. It's not always an easy proposition, what with government-wide budget freezes, the heavy and difficult workload of working at FDA, the myriad of factors influencing ev...
  • FDA's Influential Science Board Seeks New Members

    US regulators are calling for new nominees to serve on the US Food and Drug Administration's (FDA) Science Board , an advisory committee charged with providing advice to the agency regarding science and technology issues impacting public health. The board has been highly influential on FDA in recent years. A landmark report issued by the committee in 2007 noted serious scientific deficiencies at the agency, and led to systematic changes meant to address the concerns. ...
  • CDER Unveils Five-Year Plan Focused on Smart Regulation, Scientific Innovation and Lean Management

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released its strategic regulatory plan for the upcoming five-year period, reflecting a refined vision and new realities it says it will need to face in order to advance the regulation of pharmaceutical and biological products. FDA and its regulatory centers for drugs, devices and biologics regulatory put out targeted plans meant to guide the agency and its component centers ove...
  • FDA Says Focus on Regulatory Science Key to Advancing Personalized Medicine and Helping Patients

    A new report published by the US Food and Drug Administration (FDA) seeks to further advance its frequent narrative that good regulation is good for both business and the American public, this time focusing on how its efforts in the area have advanced personalized medicine. Background The term "regulatory science," which FDA defines as the "science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regula...