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  • Senators Call on FDA to Strengthen Antibiotic Monitoring

    A group of 13 senators is calling on the US Food and Drug Administration (FDA) to tighten the requirements of recently-released antibiotics guidance documents . The guidance documents, released in April 2012, called for manufacturers to voluntarily limit the "injudicious" use of their antibiotic products in food-producing animals. At the time, FDA said it had received voluntary assurances from Pfizer, Eli Lilly and Merck that they would implement the changes. Definitio...
  • User Fees Published for Drugs, Biosimilar Products

    The US Food and Drug Administration (FDA) has published information regarding user fees payable to the agency between October 2012 and September 2013 for prescription drug, veterinary and biosimilar products. The fees are part of the FDA Safety and Innovation Act (FDASIA) -a sweeping piece of legislation containing numerous user fee bills, including the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BSUFA) . The fees for all products will st...
  • 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...
  • EU Guidance Provides 'Assessment Strategy' For Environmental Testing of Veterinary Drugs

    The European Medicines Agency (EMA) has released brand new guidance for manufacturers of veterinary products containing substances with the potential to accumulate both inside and outside of an animal. EMA's 25 July Guidance on the assessment of persistent, bioaccumulate and toxic (PBT) or very persistent and very bioaccumulate (vPvB) substances in veterinary medicine applies is intended to "provide an assessment strategy" for conducting environmental testing of the ...
  • US Agency Launches Investigation Into Veterinary Pharmaceutical Industry

    The US Federal Trade Commission (FTC) is announcing an investigation into competitive issues in the veterinary pharmaceuticals market after concerns were raised to it regarding the pricing of medications and possible anti-competitive issues. "American consumers spend a tremendous amount of money on medications for their pets every year," FTC Chairman Jon Leibowitz explained in a statement. "High prices on these medications mean that consumers have less money for necessit...
  • 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...
  • 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...
  • EMA Releases Guidance on Electronic Submission of Veterinary Applications

    The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format. The document, Electronic submission of veterinary dossiers: Questions and answers , provides answers to a number of common questions. Sponsors submitting via the centralized application procedure are encouraged-but not required-to submit their veterinary dossiers to EMA, though sponsor...
  • Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types

    Based on a 7 May agreement between Brazil's National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA), companies will be allowed to produce drugs for both veterinary and human use in the same manufacturing facility as long as the active ingredients and excipients have been approved for both human and veterinary use. Companies wishing to take advantage of this new approach will be required to obtain Certificates of Good Ma...
  • 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 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...