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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Sets Up Antimicrobial Monitoring Program (14 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Sets out 5-Year Strategy for Antimicrobial Monitoring Program The European Medicines Agency (EMA) has published a draft strategy for the next five years of its program to monitor the use of antimicrobials. Over the period covered by the document, EMA plans to continue expanding the number of countries from which it gathers data with a view to ultimately covering ev...
  • Regulatory NewsRegulatory News

    Health Canada to Require Precautionary Statements in Antimicrobial Labels

    As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling. The proposal, which was announced alongside the kickoff of World Antibiotic Awareness Week , comes as bacteria are increasingly stronger, more resistant to antibiotics and therefore more lethal. As part of its federal action plan on antimicrobial resis...
  • Regulatory NewsRegulatory News

    FDA Finalizes Policy Meant to Limit Use of Antibiotics in Farm Animals

    The US Food and Drug Administration (FDA) has released a long-anticipated final rule meant to limit the use of antibiotics in food-producing animals in order to limit the spread of antibiotic-resistant bacteria. The rule, known as the Veterinary Feed Directive (VFD) , has been amended to require veterinary antibiotics to be prescribed by a veterinarian "within the context of a veterinarian-client-patient relationship (VCPR)," FDA explained in an accompanying press s...
  • Regulatory NewsRegulatory News

    Senators Call for New Limits on 'Medically Important' Antibiotics

    A new bill introduced this week in the US Senate would restrict the use of "medically important" antibiotics in agriculture in the hopes of reducing the risk of bacteria developing resistance to those drugs. Background The bill, the Preventing Antibiotic Resistance Act (PARN) ( PDF ), was introduced on 2 March 2015 by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME), with support from Sens. Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA). The legisl...
  • Regulatory NewsRegulatory News

    As US Falters in Fight Against Antibiotics Over-Prescribing, EU Makes Progress

    The European Union seems to be making substantial strides in something the US thus far has been unable to do: reducing the use of antibiotics in food-producing animals. In a new report issued on 15 October 2014, the European Medicines Agency (EMA)—the EU's version of the US Food and Drug Administration (FDA)—announced that between 2010 and 2012, the sales of antibiotics for use in animals fell 15% on average across 20 European countries. While some of those countries...
  • PhRMA to FDA: Antibiotic Guidance Focuses too Much on Superiority

    The US pharmaceutical industry says a recent guidance issued by the US Food and Drug Administration (FDA) and intended to spur the development of new antibacterial therapies relies too heavily on superiority studies, potentially undermining legitimate needs and uses for drugs in light of advancing antimicrobial resistance to existing therapies. Background The draft guidance,  Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious ...
  • Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data

    • 06 December 2012
    • By
    A consumer advocacy group has filed a lawsuit against the US Food and Drug Administration (FDA) for withholding data regarding the use and sale of antibiotics used in food-producing animals, saying the denial of its Freedom of Information Act (FOIA) request for the information was "unlawful." The group, the Government Accountability Project (GAP), which bills itself as a whistleblower protection organization, said it objects to FDA withholding certain data reported to ...
  • FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

    The US Food and Drug Administration today released an order, titled, " New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition ", that is aimed at prohibiting the off-label use of cephalosporin antimicrobial drugs in certain food-producing animals. The agency found that off-label use of the antimicrobial in food-producing animals was likely to be unsafe and represent a risk to the public. The rule follows an attempt to regulate the antimi...