• Proposed Changes to Antibiotic Regulation Given More Time for Public Comment

    The US Food and Drug Administration (FDA) has extended the amount of time the public and members of industry may comment on an advanced notice of public rulemaking concerning proposed changes to the way the agency collects and tracks information about antibiotics. The regulation regards authority given to the agency under the Animal Drug User Fee Amendments Act of 2008 ( AGDUFA ), which allows FDA to require sponsors to submit annual reports detailing sales, distributi...
  • 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...
  • 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...
  • Final Guideline on Antibiotic Impurities Focuses on Manufacturing Processes

    The European Medicines Agency (EMA) has released final its final guideline on how to set specifications for impurities present in antibiotics not covered by other internationally-harmonized guidelines. European regulators note in the guidance that antibiotics produced by a fermentation process are less precise and create more product variability and impurities than do other synthetic processes. Because many of these processes-including semi-synthetic fermentation-do not ...
  • Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration

    The US Food and Drug Administration (FDA) has suffered its second setback in as many months after Magistrate Judge Theodore Katz of the District Court of New York ordered the agency to reconsider two petitions which seek to ban the use of antibiotics in animals. FDA had rejected both petitions, respectively submitted to the agency in 1999 and 2005, citing "the time and expense required to evaluate individual drug safety and to hold formal withdrawal proceedings," reports...
  • 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...
  • Hamburg: 'I Understand the Frustration' With Inefficient Regulations

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg spoke at the International Conference on Emerging Infectious Diseases, saying the agency is aware of the "dearth of new products" in the development pipeline to fight infectious diseases, and is doing everything it can to open up new and innovative regulatory pathways to speed products to market. The 11 March keynote speech by Hamburg-herself a former commissioner of health and physician-focused primaril...
  • China Finds 13 Drugs Made With Excessive Levels of Chromium

    China's State Food and Drug Administration (SFDA) announced 15 April it had found 13 pharmaceutical products to have been manufactured with excessive levels of chromium and was suspending the sale of those products, reports The Wall Street Journal . The chromium was found to have emanated from drug-capsule manufacturers in the Zhejiang province in China, which were reported to be using industrial gelatin instead of gelatin marked for human consumption. The industrial-gr...
  • FDA Seeks to Limit Antibiotics in Animal Feed

    The Food and Drug Administration has released guidance asking drug companies to voluntarily limit the use of certain antibiotics in animal feed in response to concerns that their overuse in livestock contributes to the development of drug-resistant bacteria.  "It is critical that we take action to protect public health," said FDA Commissioner Margaret A. Hamburg, MD. The agency has published three documents to address the issue: (1) A final guidance that...
  • FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

    Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the "injudicious" use of antibiotics in food-producing animals , three pharmaceutical manufacturers said they were agreeing to change the labeling on their veterinary antibiotics to exclude indications for food-producing animals, reports Bloomberg . FDA Deputy Commissioner for Foods Michael Taylor said he has assurances from Pfizer Inc., Eli Lilly & Co. and Merck & Co.-three o...
  • FDA Releases New Guidance To Voluntarily Limit Many Uses of Antibiotics in Animals

    The US Food and Drug Administration (FDA) released three new guidance documents that seek to phase out the "injudicious use" of antibiotics in food-producing animals through voluntary actions through voluntary actions by industry. The guidances follow an order in late March 2012 by US Magistrate Judge Theodore Katz for FDA to remove antibiotics from animal feed or withdraw the non-therapeutic uses of those drugs entirely . The newly-released guidance calls for "judici...