• 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...
  • FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

    The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted without first filing an investigational new drug (IND) application with US regulators. Background: The FMT Precedent In recent months, FDA has proven to be somewhat amicable to the idea of extending enforcement discretion-that is, expressing that it won't punish an entity-when h...
  • 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....
  • 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...