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  • FDA Using Twitter, Telenovelas and Translations to Reach Non-English Speakers

    If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're probably fluent in English and well-versed in medical terminology. Many Americans, though, can't read, can't read or speak English, or can't read or speak English well enough to understand the medical terminology that is necessary to interpret the labels on medical products like...
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    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...
  • Chinese Provinces Told to Advance Regulatory Science and Technology

    China's Food and Drug Administration (CFDA) has issued a notice to the country's provinces and municipalities instructing them to prioritize scientific and technological innovation in order to bolster food and drug regulation in keeping with the Party's Long-term Scientific and Technological Development Plan (2006-2020).  In accordance with the requirements of the State Council on institutional reform and transformation, the notice instructs local food and drug r...
  • Regulatory Reconnaissance (2 August 2013)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance. In Focus: "Would Have Written About These" Highlights BIO Whitepaper Calls for 12 Years of Biologics Exclusivity in Trade Deal ( BIO ) ( BIO ) BIO, PhRMA, AdvaMed, GPhA, MITA Join Together to Support Senate Bill to Exempt FDA User Fees from Se...
  • With Eye to Regulatory Science, Toxicology Program Seeks Lists of Genes to Bolster Safety

    The US Food and Drug Administration (FDA) is widely recognized as the country's chief federal regulator of healthcare products, including pharmaceuticals, medical devices and biological products. Lesser-known-but still important-is another federal program known as the  National Toxicology Program (NTP) , which works to help agencies to understand and accept the toxicological profiles of many chemicals. Now the NTP is announcing its intent to identify and prioritize a...
  • FDA Announces Major Funding for WHO to Support Regulatory Capacity, Harmonization

    US regulators have announced a five-year, multimillion-dollar contract with the World Health Organization (WHO) intended to support regulatory science and enhance global regulatory capacity through improved harmonization and the development of standards. The Office of International Programs The funding opportunity is made available through FDA's Office of International Programs (OIP), now headed by John Taylor, acting deputy commissioner, and Mary Lou Valdez, associat...
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    Fecal Transplant—a Very Unusual Treatment Method

    Could anyone imagine a medical condition that would warrant administering a stool specimen from a donor? Such treatment would seemingly belie the "Above all, do no harm" axiom thought to be part of the Hippocratic oath. 1 It just so happens that such treatment first occurred more than 50 years ago, and continues today. In 1958, doctors in Denver, Colorado, administered donor feces by enema to patients with fulminant, life-threatening pseudomembranous enterocolitis, an ac...
  • FDA Publishes Wish List of Regulatory Science Projects, Plans to Spend up to $50 Million

    US regulators have published a new agency contracting announcement regarding advanced research and development for regulatory science, saying it wants to "advance the state of the art and achieve improvements" in how healthcare products are evaluated, adding that it is prepared to spend as much as $50 million on the effort. Background The term "regulatory science," which FDA defines as the "science of developing new tools, standards and approaches to assess the safety, ...