• Regulatory Bodies to Assess Alternate Vaccine Testing Methods

    • 27 July 2012
    The US Food and Drug Administration (FDA) is widely known as the country's chief federal regulator of biological products. Lesser-known-but still important-is another federal program known as the National Toxicology Program (NTP) , which works to help agencies to understand and accept the toxicological profiles of many chemicals, including those used in vaccines. The NTP's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) on Thursday (...
  • 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...
  • Presidential Commission Looking to Study Ethical Issues of Animal Rule in Pediatric Populations

    • 28 June 2012
    A Presidential Commission in charge of studying bioethics wants to know: what are the ethical issues associated with studying medical countermeasures in children? In a 28 June Federal Register posting, the Presidential Commission for the Study of Bioethical Issues-a commission formed in 2009 specifically to look at ethical issues related to "biomedicine and related areas of science and technology"-said it wants to look deeper into the legal, ethical and social issues o...
  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • 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 ...
  • IOM Explores Regulatory Hurdles of Animal Research

    A new workshop summary from the Institute of Medicine (IOM) calls upon researchers to consider the judicious use of animals used in global neuroscience research. In its 29 May release of International Animal Research Regulations: Impact on Neuroscience Research , IOM's group of experts convened under the auspices of the Forum on Neuroscience and Nervous System Disorders note neuroscience research has specific and unique implications for animals used in research. The ...
  • 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...
  • Warning Letter Analysis: Animal Food Manufacturer Cited for Marketing Violations

    A warning letter released by the US Food and Drug Administration (FDA) on 24 May cites a manufacturer of animal food products for promoting its products using claims restricted by law to animal drugs approved by the agency. Process Managers, LLC (Veterinary Pharmaceuticals) A warning letter sent to a Kentucky-based manufacturer of animal health products, Process Managers, LLC, alleges two of the company's food products are marketed using claims reserved for approv...
  • J&J Antibiotic Approved Via 'Animal Rule' Pathway

    • 30 April 2012
    After being backed by a US Food and Drug Administration (FDA) advisory committee , life sciences manufacturer Johnson & Johnson (J&J) has won FDA approval for Levaquin (levofloxacin), an antibiotic intended to treat pneumonic plague. The drug's approval is notable because it utilizes a rarely-used approval pathway known as the 'Animal Rule' pathway. The pathway allows sponsors of products intended to treat very dangerous or contagious conditions to forgo clinica...
  • EMA Expands Access to Electronic Submission Gateway Pilot to Include Veterinary Products

    The European Medicines Agency (EMA) announced 25 April it will expand access to its electronic submission gateway pilot program to include veterinary medicines. The program, dubbed the eSubmission Gateway, is an "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA. EMA had recently expanded the program, which was launched as a pilot program in January 2012, to include all human medicines after is saw "an increase in the spe...
  • FDA Releases Strategic Plan for Veterinary Medicine Program

    The US Food and Drug Administration (FDA) has released a new strategic plan for its veterinary medicine program for the 2012-2016 period, outlining the regulatory goals for FDA's Center for Veterinary Medicine. The plan, intertwined with FDA's plan for the Center for Food Safety and Applied Nutrition (CFSAN), provides seven "strategic program goals" and dozens of specific initiatives meant to carry out those strategic program goals. FDA's Foods and Veterinary Medicine...
  • FDA Close to Approving J&J Drug Via Animal Rule Pathway

    Advisers from the US Food and Drug Administration (FDA) are backing a Levaquin, a drug candidate manufactured by Johnson & Johnson, despite the drug not undergoing human clinical trials, reports Fierce Pharma . The backing would involve the extremely rare use of an approval pathway known as the 'Animal Rule' pathway, which was created after a series of anthrax-based terror attacks in 2001 prompted FDA and other governmental officials to seek an approval pathway for ...