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  • Regulatory NewsRegulatory News

    Three EU Agencies Collaborate on Drug Resistance Study

    Three EU agencies have announced they will work together in the hopes of better understanding one of today's most pressing global healthcare issues: Antimicrobial resistance (AMR). Global and Historical Context Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk of AMR in...
  • 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    The US Food and Drug Administration (FDA) has published a new draft guidance on the development of antibacterial drugs intended to treat "uncomplicated" gonorrhea, the latest in a string of guidance documents reflecting the agency's new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...
  • Regulatory NewsRegulatory News

    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 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 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...
  • 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...