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  • Regulatory NewsRegulatory News

    EU Committee Takes on Adverse Event Reporting for Veterinary Drugs

    Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting. Background EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done prima...
  • Large Carriers Cave to Animal Rights Groups, Placing New Burdens on Preclinical Research

    • 21 September 2012
    • By
    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...
  • Feature ArticlesFeature Articles

    Tarantulas: Possible Lifesavers?

    • 07 August 2012
    • By
    In the past, I have written about many creatures in the animal kingdom, and several of them were on the top of the most hated and feared list. Rats, spiders and snakes are prime examples. My earlier article about spiders described how spider webs could be used to fashion artificial ligaments or tendons. 1 Tarantulas, another arachnid in that species, may prove valuable in treating a number of pathologies. This article will describe them, their venom, mechanisms of acti...
  • FDA Releases Draft Guidance for Veterinary Trials

    The US Food and Drug Administration's Center for Veterinary Medicine (CVM) has released a draft guidance detailing best practices for setting active controls in animal studies used to demonstrate effectiveness of medicinal products in cats, dogs and horses. As with clinical trials, FDA said the health and general welfare of study subjects should be an active consideration when determining whether to use placebo controls or active controls, which are defined as being a "k...
  • Feature ArticlesFeature Articles

    Pythons—A Model to Study Human Heart Disease?

    • 15 June 2012
    • By
    Many of my previous articles for RAPS have featured a host of disparate animals that are or could be used in medicine or in medical research, including leeches, maggots, rats, spiders, whipworms, Gila monsters and zebrafish. Now, there is new evidence to include Burmese pythons on this distinguished list. This snake species may be used to develop drugs to treat human heart disease. 1 In anticipation of this event, it would be prudent to know more about  Burmese pyth...
  • EMA Releases New Draft Guideline on Ensuring the Quality of Animal-based Biotechnology

    The European Medicines Agency (EMA) released a new draft guideline for sponsors obtaining biologically active substances from transgenic animals on 31 May, saying new guidance was necessary to help manufacturers achieve quality measures when using the biotechnology. EMA explained the proposed guidance adheres to many of the same specific aspects of quality guidance already in place for other recombinant production systems. "As is the case with other biotechnologically ...
  • 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 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...
  • Draft Guideline Released by EMA on Pharmacological ADIs for Veterinary Medicinal Products

    The European Medicines Agency (EMA)  released a draft guideline  on 23 January on pharmacological acceptable daily intake (ADI), titled Guideline on the approach to establish a pharmacological ADI . The guideline advises when to establish a pharmacological ADI, how to conduct studies and what endpoints must be addressed. EU legislation requires that any food produced from animals that are treated with veterinary medicinal products be free from medicinal residu...
  • FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

    The US Food and Drug Administration today released an order, titled, " New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition ", that is aimed at prohibiting the off-label use of cephalosporin antimicrobial drugs in certain food-producing animals. The agency found that off-label use of the antimicrobial in food-producing animals was likely to be unsafe and represent a risk to the public. The rule follows an attempt to regulate the antimi...