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  • FDA Issues New Draft Guidance on Bacterial Pneumonia Treatments

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is intended to provide clearer expectations for developers of therapies to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The guidance, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment , replaces an earlier 2010 guidance by the same name in the hopes of providing additional and updated ...
  • FDA's New Veterinary Antibiotics Strategy Yields Early Results

    Several months after first launching a new regulatory approach intended to voluntarily limit the prescribing of non-essential antibiotics in food-producing animals, the US Food and Drug Administration (FDA) is already seeing success. Background FDA's antibiotic use policy  first began to take shape  in the 1970s, and in recent years has been subject to intense scrutiny from outside  advocates ,  former FDA officials ,  government investigators ,...
  • FDA Proposes Making Antibiotic Monitoring Report More Useful

    Nearly five years after the passage of the Animal Drug User Fee Amendments Act (ADUFA) of 2008, the US Food and Drug Administration (FDA) is proposing to expand upon its data reporting requirements, saying companies will need to include even more data on the antimicrobial drugs they sell for use in food-producing animals. Background The policy is being advanced through proposed rulemaking released on 26 September 2013 by the agency. It was first released as a propose...
  • 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...
  • Eligibility for Antibiotic Incentives Focus of Upcoming FDA Meeting

    At what point does a pathogen cross the threshold from dangerous nuisance to a threat to public health? The US Food and Drug Administration (FDA) wants to know , and the definition it decides on could have big implications for developers of antibiotic and antifungal products. The question goes back to the July 2012 passage of the FDA Safety and Innovation Act (FDASIA) , which contained a provision known as the Generating Antibiotic Incentives Now (GAIN) Act. GAIN amen...
  • 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...
  • Pfizer Receives Untitled Letter for Presentation of Drug Risks

    • 06 July 2012
    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter to pharmaceutical manufacturing giant Pfizer for allegedly marketing its extended-released antibiotic Zmax (azithromycin) using misleading, unproven and incomplete information. The 19 June untitled letter focuses on a brochure produced by Pfizer to promote Zmax. FDA claims the company minimized several risks factors-including severe and potentially f...
  • 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 ...
  • 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...