• Report Claims Staffing Problems Continue to Plague FDA

    The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts to recruit the best regulatory staff it can get, says a new report from the Partnership for Public Service (PPS). The group acts as a sort of advocacy group for those working in, or hoping to work in, the government. PPS said it had recently been approached by the Pew Cha...
  • Fear of Disease's Deadly Potential Leads to Regulatory Science Initiative

    The US Food and Drug Administration (FDA) plans to hold a meeting on the regulatory science issues surrounding the development of antibiotics to treat Burkholderia pseudomallei  -a dangerous gram-negative bacterial pathogen capable of killing a high percentage of those it infects. FDA is holding the workshop with a number of other agencies-most of which are military-related-in the hopes of developing classes of products known generally as medical countermeasures (M...
  • FDA in Sustained Push to Show Public Benefits of Regulatory Science

    Can regulatory science -that is, the use of various scientific disciplines to make informed decisions about the safety, efficacy or quality of a particular product-ever be exciting to the average citizen? Regulators with the US Food and Drug Administration (FDA) hope so, and are in the midst of a sustained public relations push to give the burgeoning field a bit more exposure and appreciation. In a posting on 6 November, FDA's Susan Kelly, managing editor of consume...
  • Restricted Travel, Conference Budgets Could Harm Regulators, Say Critics

    Government oversight bodies wary of fraudulent and unscrupulous expenditures made during agency-sponsored conferences have recently begun to crack down on how much money the agencies can spend, potentially to the detriment of legitimate exchanges of scientific information, say critics. After reports were raised about the General Services Administration (GSA) spending huge sums on an extravagant Las Vegas conference featuring a clown, mind-reader and $7,000 in sushi rol...
  • Regulators: Need to Pay More Attention to Regulatory Capacity of Developing World

    • 24 October 2012
    Little attention has been paid to the regulatory systems in low- and middle-income countries across the world, causing a huge and negative impact on global public health, argue three employees of the US Food and Drug Administration (FDA) in the latest issue of the Public Library of Science Medicine (PLoS Medicine) . The article, Strengthening Medical Product Regulation in Low- and Middle-Income Countries , was authored by Charles Preston, Mary Lou Valdez and Katherin...
  • Feature ArticlesFeature Articles

    Bacillus Calmette-Guerin--Another Surprise!

    • 19 October 2012
    After a physical several years ago, my wife learned that red and white blood cells were detected in her urine. The doctor ordered an intravenous pyelogram to determine the cause. In this test, an iodine-containing contrast material is injected into the bloodstream and a series of X-rays are then taken at timed intervals. The resulting films allow the radiologist to view the entire urinary tract. Unfortunately, the diagnosis revealed evidence of bladder cancer, a well-di...
  • New Chemical Testing Method to Reduce Reliance on Animal Eye Testing

    • 10 October 2012
    The National Toxicology Program (NTP) has announced a new classification criterion that it says should require between 50% and 83% fewer animals to be used during testing to determine whether a chemical is hazardous to the eye. The NTP and its various subprograms are responsible for bringing together more than a dozen federal agencies to generate and harmonize testing standards for toxic substances. Through its committees, it evaluates safety testing methods and strategi...
  • In Wide-Ranging Interview, Hamburg Looks Back on First Four Years as Commissioner

    US regulators are increasingly reaching out to partner with their foreign counterparts, transitioning from a domestic agency to one with a global focus, said US Food and Drug Administration (FDA) Commissioner Margaret Hamburg in a lengthy appearance sponsored by the Center for Strategic and International Studies (CSIS). Hamburg's 1 October appearance at CSIS was meant to be a retrospective look at the commissioner's four-year tenure as head of the agency, and she offer...
  • FDA Highlights Regulatory Science in Outreach to Public

    "When someone uses the word 'science,' you might think of chemistry, biology, or physics, to name just a few fields," writes the US Food and Drug Administration (FDA) on a new webpage aimed at the general public. "You probably wouldn't think 'regulatory science.'" That's something FDA hopes to change, the agency writes. FDA officials are now touting the impact of regulatory science to the public, hoping to make consumers more aware of the complexities of regulating prod...
  • FDA 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. In its 10 September Federal Register notice , FDA explains that the board is looking for those knowledgeable in a variety of fields, including pharmacology, translational medicine, clinical research, toxicology, biostatistics, m...
  • Brazil: Regulators Partner With Government to Advance Regulatory Science

    Brazil's National Health Surveillance Agency (Anvisa) and the National Council for Scientific and Technological Development (CNPq) are partnering on an initiative to financially support projects that would "significantly contribute" to innovation in the regulatory sciences, Anivsa said in a 4 September announcement. Both CNPq -- a government agency that acts to promote science in technology in Brazil -- and Anvisa jointly  published on 31 August a public...
  • New Center could be Model for Advancing Regulatory Science, Cures

    A new draft report published by the US Institute of Medicine (IOM) on the so-called "Valley of Death"-the gap between therapies exhibiting promise and those actually being approved for use in patients-explores the possibilities for leveraging the newly formed Cures Acceleration Network (CAN). CAN was formed out of the 2010 Patient Protection and Affordable Care Act (PPACA) , and now resides within the National Institutes of Health's (NIH) National Center for Advancing...