• Regulatory NewsRegulatory News

    FDA's Veterinary Regulators Eye Dozens of Policy Changes in 2015

    The US Food and Drug Administration's (FDA) veterinary regulatory division, the Center for Veterinary Medicine (CVM), plans to release 31 new or updated policies in 2015, it has confirmed. In a notice posted on FDA's website last week , CVM announced top-level details about which guidance documents it plans to release in the coming year. Guidance documents are non-binding expressions of policy, and indicate how FDA wants members of the life science industry to comply wi...
  • Regulatory NewsRegulatory News

    Even Pharmaceutical Marketing for Dogs can be Improper, FDA Says in Warning Letter

    When the US Food and Drug Administration (FDA) goes after pharmaceutical companies for violating federal marketing regulations, it usually goes after makers of pharmaceuticals for humans. But as a recent and rare Warning Letter illustrates, sometimes veterinary companies fall under the agency's scrutiny as well. In a 2 April 2014 letter to AB Science , a French pharmaceutical manufacturer, FDA veterinary regulators cited the company for allegedly marketing its veterinar...
  • Regulatory NewsRegulatory News

    What's a Rare Disease for Dogs? FDA Proposes Maintaining Current Levels for Major Species

    Drug regulation is in many ways as much about incentives as it is about requirements. Especially for drugs intended for smaller populations, an incentive—a free review voucher or a speedy review time, for example—may be the difference between a drug existing as a concept or as one available to consumers. Background In the US, patients have long benefited from the Orphan Drug Act , which defines a rare disease as one affecting fewer than 200,000 patients in a given year...
  • FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted

    The US Food and Drug Administration (FDA) has issued a final regulation which it says will allow it to increase the transparency of its veterinary drug approval decisions. The 14 March 2014 announcement in the US Federal Register , a compendium of all regulatory decisions made by US government entities, aims to better work within an unusual statutory confinements. Background When a human pharmaceutical product is approved, the materials used to support its approval ...
  • FDA's Veterinary Division Plans to Release Dozens of Regulatory Guidances in 2014

    US veterinary product regulators from the Center for Veterinary Medicine (CVM) have released the first of the US Food and Drug Administration's (FDA) guidance agendas for the year, highlighting a range of policy initiatives they aim to undertake in the coming months. FDA, CVM's parent organization, is in the practice of releasing so-called "guidance agendas" at the beginning of each year, and sometimes updating it several times throughout the year. The intent is to allow...
  • FDA Says Veterinary Pharmaceutical Manufacturer Plagued by Bugs, CGMP Deficiencies

    With the steady drumbeat of Form 483s, Warning Letters and Untitled Letters sent by the US Food and Drug Administration (FDA) to pharmaceutical, medical device and dietary supplement manufacturers, it can be difficult to remember that those aren't the only life science industries FDA regulates-a fact that was brought into clear view last week when the agency sent a New Kersey-based veterinary pharmaceutical company an Advisory Action Letter. Rare Letter, Common Problems ...
  • US Regulators Slam Superbug Report as Simplistic and Alarmist

    The US Food and Drug Administration (FDA) on Monday issued a lengthy-and rare-statement fighting back against a report issued by the Environmental Working, an advocacy group focused in part on antibiotic resistance and the judicious use of antibiotics, saying the group's analysis was built on an oversimplification of publicly available data. Background Various news reports in recent years have highlighted the role of the overuse of antibiotics in food-producing animals ...
  • Genetically Modified Food, Nanomaterials among Topics Addressed in Planned 2013 CVM Guidances

    The US Food and Drug Administration (FDA) has announced guidance documents its Center for Veterinary Medicines (CVM) plans to publish by the end of the 2013 calendar year, including several topics that could be harbingers for the rest of the pharmaceutical industry. The publication of the guidance list follows similar publications of documents for medical device and pharmaceutical products , and includes a number of important guidance documents. Of note: Draft Guida...
  • 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...
  • 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...
  • 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...
  • Antimicrobial Resistance Monitoring Policy Updated by FDA

    An updated strategic plan detailing the goals of the Center for Veterinary Medicine's (CVM) National Antimicrobial Resistance Monitoring System (NARMS) aims to change the way the agency samples animals, improve its data recording and reporting methods, strengthen collaborative partnerships between national and international agencies and harmonize international reporting standards. CVM, the US Food and Drug Administration's (FDA) veterinary regulatory oversight body, uses...