• FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

    The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by ...
  • Antimicrobial Resistance Monitoring Policy Updated by FDA

    An updated strategic plan detailing the goals of the Center for Veterinary Medicine's (CVM) National Antimicrobial Resistance Monitoring System (NARMS) aims to change the way the agency samples animals, improve its data recording and reporting methods, strengthen collaborative partnerships between national and international agencies and harmonize international reporting standards. CVM, the US Food and Drug Administration's (FDA) veterinary regulatory oversight body, uses...
  • Judge Orders FDA To Remove Antibiotics from Animal Feed

    A federal judge ruled this week that The US Food and Drug Administration (FDA) must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics, reports Reuters . The 22 March ruling by US Magistrate Judge Theodore Katz comes after mounting concerns about antibiotic resistance and emerging so-called "superbugs" being seen as a threat to human health. Katz noted FDA had recently ...
  • WHO's Chan Calls on Regulators to Curb Use of Antibiotics

    World Health Organization Director-General Dr. Margaret Chan spoke before a gathering of delegates from EU Member States on the subject of antimicrobial resistance, calling the matter a "global threat to health" and one requiring the intervention of regulators. Chan praised several EU nations-in particular Denmark-for their work in curbing antibiotic use in otherwise health animals, but noted the problem is a global one requiring a global response. Surveillance, in parti...
  • Woodcock Touts FDA Success in Drug Approval

    The US Food and Drug Administration's (FDA) Director for the Center for Drug Research and Evaluation (CDER), Janet Woodcock, testified before the House Energy and Commerce Committee on 8 March to advocate for the passage of the Prescription Drug User Fee Act ( PDUFA ) and used the opportunity to tout FDA's recent drug approval accomplishments. Woodcock, the nation's top drug regulatory official, was also happy to cite numbers showing FDA was able to approve most drugs ...
  • GAO: FDA Enforcement of Up-To-Date Information on Antibiotic Drug Labels Lacking

    An investigation by the US Government Accountability Office (GAO) has found that the US Food and Drug Administration (FDA) "has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints." Breakpoints are the "concentrations at which bacteria are categorized as susceptible to an antibiotic," and are used to ensure that adequate doses are administered. Inadequate doses of an antibiotic can lead to increased rates of antibiotic-resistant s...