• In First for Animal Rule Pathway, FDA Approves GSK's Raxibacumab

    US pharmaceutical regulators have granted approval to GlaxoSmithKline's raxibacumab, a monoclonal antibody that is among the only products-and the first biologic product-to be approved through the US Food and Drug Administration's (FDA) animal efficacy rule, better known as the Animal Rule pathway. The pathway was formed shortly after the terror attacks of 2001, which included a harrowing series of incidents in which spores of anthrax were sent through the US postal sy...
  • Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

    • 13 December 2012
    A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility. The company, Performance Products Inc (PPI), was accused of "significant deviations of Current Good Manufacturing Practice (CGMP) regulations" in the 20 November 2012 letter. PPI manufactures a number of products aimed at bovine and equine species, with most of those products being probiotic in nature. The company's website boats about it...
  • FDA Launches Renewal Process for Animal Drug User Fees With New Proposals

    • 04 December 2012
    The US Food and Drug Administration (FDA) is preparing for two meetings on both branded and generic veterinary pharmaceutical products, part of the impending renewal of two user fee acts meant to fund the agency's reviews and other regulatory activities in return for more accountability. The two user fee bills-the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) -act in much the same way as those for human prescription drug products, med...
  • Even Animals Want Tasty Drugs, Argues EMA

    Animal drug products may not be expected to meet the same standards for safety and efficacy as their human-intended counterparts, but that doesn't mean that their eventual recipients don't appreciate a product that's easy on both their taste buds and sense of smell. That's the finding of a new draft guideline out from the European Medicines Agency (EMA), On the Demonstration of Palatability of Veterinary Medicinal Products , which lays out the requirements for veter...
  • Animal Research Oversight in Need of Reform, Argues Researcher

    • 09 November 2012
    Are Institutional Animal Care and Use Committees (IACUCs)-groups used to ensure research conducted on animals meets basic ethical standards-meeting their ethical responsibilities and the original intent of Congress? Not even close, argues a researcher in the latest issue of the British Medical Journal . Writing in the 6 November 2012 issue of BMJ , Lawrence Arthur Hansen, a researcher at the University of California San Diego's Department of Neurosciences and Patho...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...
  • 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...
  • NIH Initiative Hopes to Improve How Preclinical Testing is Reported

    • 11 October 2012
    The National Institutes of Health (NIH) has announced a set of consensus recommendations it says will improve the way preclinical animal studies are designed and conducted, ultimately making them easier to reproduce and understand. The problem, explains NIH, is the gap between conducting animal studies and being able to study the effect of a drug in human trials. "Positive results from animal studies are sometimes difficult to translate into successful clinical trials,...
  • New Chemical Testing Method to Reduce Reliance on Animal Eye Testing

    • 10 October 2012
    The National Toxicology Program (NTP) has announced a new classification criterion that it says should require between 50% and 83% fewer animals to be used during testing to determine whether a chemical is hazardous to the eye. The NTP and its various subprograms are responsible for bringing together more than a dozen federal agencies to generate and harmonize testing standards for toxic substances. Through its committees, it evaluates safety testing methods and strategi...
  • Large Carriers Cave to Animal Rights Groups, Placing New Burdens on Preclinical Research

    • 21 September 2012
    Conducting preclinical research is likely to become even more difficult under new policies announced by major cargo carriers, reports Scientific American . FedEx and UPS, two of the world's largest shipment and logistics companies, have announced respective agreements with People for the Ethical Treatment of Animals (PETA) to prevent the shipment of mammals for use in preclinical testing. The move is likely to place additional burdens on clinical researchers, who r...
  • FTC Raises Concerns About Quality, Authenticity of Pet Medications

    The Federal Trade Commission (FTC) has released the draft agenda for an upcoming meeting that could shake up the veterinary pharmaceutical sector. The meeting, "Competition & Consumer Protection Issues in the Pet Medications Industry," was first announced in June 2012, and was called in response to FTC's perception that consumer-focused veterinary medications were subject to anti-competitive pricing and access issues. "American consumers spend a tremendous amount ...
  • FDA Changes Regulation to Allow Some Carcinogenic Products to be Used in Animals

    The US Food and Drug Administration (FDA) has released an updated regulation that redefines the acceptable concentration levels of a carcinogen allowed in food-producing animals. The regulation, Regulation of Carcinogenic Compounds in Food-Producing Animals , changes two definitions in particular: "S o " and "S m ." S o previously referred to the concentration level of carcinogens in an animal's diet that is equal to a 1/1,000,000 risk of the animal developing c...