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  • Regulatory NewsRegulatory News

    EMA Consults on Harmonized Antibacterial Drug Development Guideline

    The European Medicines Agency (EMA) on Monday released a draft version of its guideline on developing antibacterial medicines for consultation.   The 30-page guideline, which is now on its third revision, has been updated to reflect a harmonized approach to antibacterial drug development based on the tripartite discussions between EMA, the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.   "Antimicrobial resistance is a glob...
  • Regulatory NewsRegulatory News

    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
  • Regulatory NewsRegulatory News

    Antibacterial Wash Companies Have One Year to Remove 19 Banned Ingredients, FDA Final Rule Says

    The US Food and Drug Administration (FDA) on Friday published a final rule calling on antibacterial wash manufacturers to eliminate 19 ingredients from their products within one year because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.  Triclosan (liquid soap) and triclocarban (bar soap) are among the most common of th...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Microbiology Data for Antibacterials

    The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern healthcare." The threat is compounded by the fact that while bacteria are becoming in...
  • Regulatory NewsRegulatory News

    FDA Warns Medtronic Subsidiary Over Adulterated Devices

    Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx. The letter, dated 2 June, follows an inspection of the company’s Monmouth Junction, NJ-based site from 30 November 2015 through 12 February 2016, with respect to Tyrx’s Antibacterial Envelope, Antibacterial Absorbable Envelope, which is intended to reduce the cha...
  • Regulatory NewsRegulatory News

    Experts Call for New Regulatory Pathways for Antibiotics

    Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics. At the FDA/CMS Summit in Washington, DC today, representatives from several companies developing new antibiotic treatments said that while recent initiatives such as the Generating Antibiotics Now Act (GAIN Act) have helped revitalize investment in antibiotic development, more needs to be done to encourage research and deve...
  • 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 ...
  • 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 ...
  • FDA Guidance to Allow Patients With Serious Bacterial Skin Infections to Participate in Trials More Easily

    A new guidance document released on 16 October 2013 by the US Food and Drug Administration (FDA) seeks to clarify the standards by which it will assess new applications for pharmaceutical products intended to treat acute bacterial skin and skin structure infections (ABSSSI). Such infections are distinguishable from other skin infections by their severity, and include wound infections and major (surface area greater than 75 cm 2 ) cutanenous abscesses. FDA said it does no...
  • 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...
  • 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...
  • EMA Issues Guidelines on Development of Antibacterials

    The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections . The document was approved last month at the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP) meeting, and is due to come into effect on 15 January 2012. The guideline was formulated by EMA to further clarify aspects of the antibacterial agent development process t...