• 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...
  • 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...
  • Feature ArticlesFeature Articles

    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, ...
  • FDA Looking to Improve the Generic Drug Regulatory Process, Wants Industry Input

    The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its research priorities as it looks to fulfill its statutory goals under the FDA Safety and Innovation Act (FDASIA) . Background In July 2012, FDASIA -a massive piece of legislation containing numerous FDA reform provisions and user fee bills-was passed into law, and with it the ...
  • Reagan-Udall Foundation Shows Signs of Life after Long Hiatus

    A long-dormant regulatory science program first established by the US Congress in 2007 is, for the first time in years, beginning to show signs of activity, indicating that it could soon begin to influence and enhance product safety as its founders intended. Background The foundation, known as the Reagan-Udall Foundation, is a non-governmental, independent entity founded in 2007 as part of the Food and Drug Administration Amendments Act (FDAAA) . Its creation came at ...
  • EMA Management Board Turns Focus to Regulatory Science and Faster Approvals

    In its first meeting of 2013, the European Medicines Agency's (EMA) management board turned its sights on the agency's use of regulatory science, saying EU regulators need to adopt new approaches to allow for drugs to get to patients more quickly and with a better understanding of patients' tolerance for risk-a potential boon for members of rare patient populations. In a statement, EMA said the board has already turned its attention-much as the US Food and Drug Administr...
  • FDA Should Improve Science Integrity Policy and Visitor Logs Policy, Group Argues

    A prominent science advocacy group is calling on the US Food and Drug Administration (FDA) to do a better job at explaining provisions put into place to protect the integrity of scientific data, saying agency employees likely have a difficult time understanding them in plain terms. Background The group, Union of Concerned Scientists (UCS), regularly comments on FDA matters; everything from scientific integrity at the agency (under pressure from industry , they say) to ...
  • US Regulators Consider Formation of New Advisory Subcommittee to Study 'Data Liberation'

    The US Food and Drug Administration's (FDA) Science Board-an advisory board focused on the mission and competencies of the agency-will soon meet to start the process of reassessing a landmark 2007 report in which it described FDA as being in a state of decline. Background The report, FDA Science and Mission at Risk , was prepared in 2007 by the Science Board's Subcommittee on Science and Technology. In it, the board raised three principal points against FDA: that i...
  • New Regulatory Tools Requested to Study Messaging of Regulators, Industry

    How does a regulatory agency best communicate and regulate essential messaging to stakeholders on a continual basis without being ignored? The US Food and Drug Administration (FDA) isn't necessarily sure, either, and is looking to the private sector for answers. Writing on the Federal Business Opportunities website on 4 January 2013, FDA released an addendum to an earlier contact solicitation in which it sought the expertise of an outside firm to assist it in advancing...
  • Regulatory Science Initiative Partners FDA, Medical Device Industry

    "If the U.S. wants to remain the leader in medical device innovation, we also must be the leader in regulatory science," said Jeffery Shuren, director of the US Food and Drug Administration's (FDA)'s Center for Devices and Radiological Health (CDRH) in a January 2012 meeting before members of the medical device industry. In that January meeting, part of Shuren's "FDA Town Hall" series of events meant to drum up support for the agency's activities, Shuren also hinted at...