• Regulatory NewsRegulatory News

    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
  • Regulatory NewsRegulatory News

    FDA Gonorrhea Guidance Follows Now-Familiar Framework on Antibiotic Development

    The US Food and Drug Administration (FDA) has published a new draft guidance on the development of antibacterial drugs intended to treat "uncomplicated" gonorrhea, the latest in a string of guidance documents reflecting the agency's new thinking on antibiotic development. Background In the last few years, FDA has released a bevy of guidance documents aimed at making it easier for companies to develop antibiotic products by easing requirements around clinical trials...
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    FDA Adds Three New Pathogens to GAIN Act Qualifying List, But Impact Remains Unclear

    The US Food and Drug Administration (FDA) has released an updated and final list of pathogens that are eligible for special incentives under the 2012 Generating Antibiotics Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) . Background The GAIN Act was passed in an attempt to incentivize the development of new antibiotics—a response to both growing rates of microbial resistance to antibiotics and a dearth of...
  • FDA Issues New Draft Guidance on Bacterial Pneumonia Treatments

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is intended to provide clearer expectations for developers of therapies to treat hospital-acquired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 Doubles Down on Voluntary Approach to Limiting Use of Antibiotics in Food-Producing Animals

    The US Food and Drug Administration (FDA), bowing to decades of pressure, has agreed to "significant steps" it says will limit the prescribing of antibiotics to food-producing animals in an attempt to limit the spread of antibiotic-resistant bacteria. 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 , and ev...
  • 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...
  • 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...
  • 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...