• EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines

    The European Medicines Agency (EMA) has announced the release of a new draft guideline regarding the testing of veterinary antibiotics, with regulators saying the changes provide greater detail on their expectations for demonstrating efficacy relative to a targeted microorganism. The guideline is in part intended to cut down on rates of increasing antimicrobial resistance, EMA wrote in an accompanying statement, with the theory being that ineffective drugs only serve to ...
  • FDA Proposes Electronic Submission System for Antimicrobial Use Reports

    The US Food and Drug Administration (FDA) wants to make it easier for companies to submit annual reports on the use and characteristics of antimicrobial products, a requirement of the Animal Drug User Fee Act II of 2008. The law, modeled after the prescription drug and medical device user fee acts (PDUFA/MDUFA), required manufacturers and sponsors of antimicrobial-containing products to annually report to FDA the "amount of each antimicrobial active ingredient in the...
  • EMA Concept Paper Calls for Guideline on Antimicrobial Resistance Assessments

    The European Medicines Agency (EMA) has released a new concept paper on the need for a new guideline to better quantify and control the risks of antimicrobial resistance stemming from veterinary antimicrobial products. Antimicrobial Resistance The concept paper, for a guideline on microbial resistance risk assessment , makes the case that antimicrobial resistance (AMR) is an increasingly important problem for both regulators and public health officials, and that...
  • FDA, Others Plan Meeting to Address Antimicrobial Resistance

    Three US healthcare agencies, including the US Food and Drug Administration (FDA), are planning to hold a meeting in November on the topic of antimicrobial resistance, and in particular the progress made to combat resistance and further steps to be taken. The meeting, announced in a Federal Register posting on 19 September , will also involve the Centers for Disease Control and Prevention (CDC) and the National Institutes of health (NIH), all of which are located wi...
  • 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...
  • 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...