• Regulatory NewsRegulatory News

    FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

    In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS). Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Orga...
  • Regulatory NewsRegulatory News

    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
  • US Regulators Slam Superbug Report as Simplistic and Alarmist

    The US Food and Drug Administration (FDA) on Monday issued a lengthy-and rare-statement fighting back against a report issued by the Environmental Working, an advocacy group focused in part on antibiotic resistance and the judicious use of antibiotics, saying the group's analysis was built on an oversimplification of publicly available data. Background Various news reports in recent years have highlighted the role of the overuse of antibiotics in food-producing animals ...
  • Senators Call on FDA to Strengthen Antibiotic Monitoring

    A group of 13 senators is calling on the US Food and Drug Administration (FDA) to tighten the requirements of recently-released antibiotics guidance documents . The guidance documents, released in April 2012, called for manufacturers to voluntarily limit the "injudicious" use of their antibiotic products in food-producing animals. At the time, FDA said it had received voluntary assurances from Pfizer, Eli Lilly and Merck that they would implement the changes. Definitio...
  • FDA Wants More Data on Antibiotics

    The US Food and Drug Administration (FDA) has released an advanced notice of proposed rulemaking-the precursor process for promulgating a regulation-saying it wants to reassess the information collected from industry regarding  veterinary antimicrobial drug sales, distribution and resistance data. In an advanced Federal Register posting , FDA said it is considering the changes through  statutory authority given to it under section 105 of the Animal Drug U...
  • 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...