• Regulatory NewsRegulatory News

    European Commission Responds to 'Stop Vivisection' Campaign

    The European Commission (EC) has responded to a campaign calling for an end to animal testing in the EU, saying animal testing is still necessary, but promising to accelerate efforts to reduce the need for animal testing. Background In March 2015, the Stop Vivisection campaign submitted a European Citizens' Initiative to the EC, calling for the commission to repeal Directive 2010/63/EU and replace it with new legislation that would phase out animal testing. A Eu...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
  • Regulatory NewsRegulatory News

    FDA Releases New Animal Rule Guidance With Focus on Vaccines and Animal Health

    The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens. Background In 2002, Congress authorized and FDA passed the Animal Efficacy Rule ("Animal Rule"), a regulation which permits the approval of some products based on safety testing...
  • Brazil's Anvisa to Assess Alternatives to Animal Testing

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has instructed the agency to review all regulations that require the submission of data from animal experiments to support marketing applications in order to determine situations where it would be possible to use alternative validated testing methods.  The agency is encouraging the development of alternative methods to animal testing through the Brazilian Centre for the Validation of Alterna...
  • Ethical Conundrum of Testing Medical Countermeasures on Children Focus of Upcoming FDA Meeting

    When it comes to regulatory issues, some are thornier than others. At the approval stage, regulators must ask whether the evidence supports approval, whether a product might be abused, whether use could hide other conditions, or whether other negative externalities exist. And even at the Investigational New Drug (IND) filing phase for drugs, regulators have to consider the safety of patients who could stand to benefit-or be harmed-by prospective treatment. And those conc...
  • Veterinary User Fee Bills Pass Congress, Await Obama's Signature

    US legislators in the House of Representatives this week announced the passage of a package of user fees that would enhance what the US Food and Drug Administration (FDA) collects from members of the veterinary pharmaceutical industry. Background Passage of the legislation was in many ways overshadowed by the debate over and passage of another major piece of legislation that would reform security standards for the pharmaceutical industry, known as the Safeguarding Am...
  • Legislators Reveal Text of Veterinary User Fee Bills, Free from Potential Markups

    • 08 April 2013
    US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both innovative and generic veterinary medicines. Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are, like their human prescription drug and medical device counterparts, a mechanism by which the veterinary pharmace...
  • Following FDASIA, Veterinary User Fee Bills Prepare for Congressional Scrutiny

    Congress has begun the process of taking up two bills that stand to make reforms to the user fee process for innovative and generic veterinary pharmaceutical products with the stated goals of generating faster approval times for products while providing better funding sources for the US Food and Drug Administration (FDA). Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are similar in nature to an omnibus ...
  • What Happens when Your Medical Device Has a Pulse? The Case of a Bug-Based 'Flying Syringe'

    • 19 February 2013
    Provita Pharmaceuticals isn't your average life sciences research and development company. Based out of New Jersey, it doesn't have its own multimillion-dollar research facilities or even much experience within its staff. Its CEO is a 16-year-old high school student, as are every single one of the company's 15 other staff members. Its closest association isn't with a major pharmaceutical company, but with Bergen County Technical School system. But a conceptual product ...
  • Could Cangene's Botulism Antitoxin Become the Seventh Product Approved under the Animal Rule?

    • 12 February 2013
    The so-called Animal Rule pathway, a regulatory mechanism meant to allow companies to skirt the ethical issues inherent in testing products intended to treat or prevent the effects of dangerous pathogens, could soon have another rare approval if early reports from US regulators are any indication of its safety and effectiveness. Background That product, Cangene's Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G) - (Equine), is a sterile solution of purified antibody fr...
  • After Six Years, Botulism Antitoxin Prepares for FDA Animal Rule Review

    • 11 January 2013
    The US Food and Drug Administration (FDA), which recently cleared two drugs using a unique regulatory pathway aimed at facilitating the development and approval of medical countermeasures and dangerous pathogens, may be closing in on the approval of yet a third. The Animal Rule Pathway The pathway, known as the Animal Rule pathway, was born out of the events following the 9/11 terror attacks, when spores of anthrax were sent around the country using the postal system....