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The FDA New Animal Drug Approval Process
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
Jacob Michael Froehlich, Alice Ignaszewski, Anna O’Brien
Many animal products are regulated by the United States federal government. However, the laws, regulations, and government agency which govern an individual product depend on that product’s classification. Under current federal law, most products administered or applied to animals are regulated as either an animal drug, an animal device, food for animals, a veterinary biologic, or a pesticide. Animal drugs, animal devices, and food for animals are regulated by the US Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM). Veterinary biologics are regulated by the Animal and Plant Health Inspection Service (APHIS)’s Center for Veterinary Biologics (CVB) of the US Department of Agriculture (USDA), while pesticides are regulated by the US Environmental Protection Agency (EPA).
Risk Assessment and Regulatory Toxicology
Published in Frank A. Barile, Barile’s Clinical Toxicology, 2019
The FDA is under the jurisdiction of the Department of Health and Human Services (HHS) and consists of nine centers: Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), Office of the Commissioner (OC), and the Office of Regulatory Affairs (ORA).
Overview of Drug Development
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
James A. Popp, Jeffery A. Engelhardt
The major components of the FDA include the CDER, the Center for Veterinary Medicine, the Center for Devices and Radiological Health, the Center for Food Safety and Applied Nutrition, and the National Center for Toxicological Research (NCTR). The centers that are based in the Washington, DC, metropolitan area have regulatory responsibility and interact directly with pharmaceutical companies on specific drug development issues and drug approvals. In contrast, the NCTR, located in central Arkansas, has a primary research function to address toxicology issues that are important to the decision-making activities of the centers.
In-use stability studies: guidelines and challenges
Published in Drug Development and Industrial Pharmacy, 2021
USFDA, Center for Veterinary Medicine published a guidance for industry on In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products in November 2020 [9]. This guidance is concerned with in-use stability studies and associated labeling statements for multiple-dose injectable animal drug products where a product container is opened by needle-punctured way. For multiple-dose injectable drug products proposed for human use, the volume limit is of 30 ml for container. Unless otherwise labeled, a 28 day in-use period associated with multiple-dose injectable drug products intended for human use is there when supported by compliance to antimicrobial effectiveness testing per US pharmacopeia requirements. Multiple-dose injectable drug products for animal use have no volume limit and are frequently supplied in much larger containers. Moreover, some species of animal weigh less than humans and their individual doses are often smaller than those human use. Per se, more punctures and a longer in-use period may be appropriate to injectable animal drug products in multiple-dose container compared to human drug products. Certain drug products and their anticipated use pose specific challenges and will be handled on a case-by-case basis.
Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches
Published in Journal of Dietary Supplements, 2020
Larry A. Walker, Igor Koturbash, Rick Kingston, Mahmoud A. ElSohly, Charles Ryan Yates, Bill J. Gurley, Ikhlas Khan
Conceptually, this type of approach has been used for conditional pesticide registrations by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (see U.S. Environmental Protection Agency 2020). Though these regulations have a far different and wide-ranging scope, their application to the conditional registration of “spot on” pet flea and tick pesticides including pyrethroid-based products illustrates the potential utility. In this example, EPA worked with the FDA’s Center for Veterinary Medicine, manufacturers associations, registrants, and veterinary medical groups to tailor a program within the FIFRA guidelines to require enhanced adverse event reporting. This involved a two-year conditional registration period, which included a detailed reporting of all pet related adverse events, a requirement which had not been included in current EPA adverse event reporting regulations. This allowed EPA the opportunity to monitor the safety profile of products suspected of producing unreasonable adverse events amongst treated pets (U.S. Environmental Protection Agency 2019), after which time the manufacturer could petition for full registration based on the track record of safety that had been documented.
Companion Animal Studies: Slipping Through a Research Oversight Gap
Published in The American Journal of Bioethics, 2018
Rebecca L. Walker, Jill A. Fisher
In the United States, oversight of animal research is typically conducted by institutional animal care and use committees (IACUCs), which are mandated both by the Animal Welfare Act and by the Public Health Service. Yet, this oversight structure generally contains features that may limit the protections that animals receive (Walker 2006). Most relevant for CALS, IACUC review, unlike in human subject research, does not require a risk–benefit analysis of individual animal research protocols (Carbone 2014). While federal funding mechanisms require assessment of the science value of the research, this is not the same as balancing potential (or actual) harms to animals with proposed benefit to animals and humans. Further, for studies that are funded by private sources—as studies like CALS are likely to be—even an impartial science value assessment may be missing. Similarly, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) requires evidence of a “rational basis” to undertake companion animal clinical trials (Hampshire 2003, 193) and subsequent reporting of any adverse experiences, but this also does not amount to a risk–benefit analysis. Further, it is unclear from the case description whether CALS falls under CVM oversight, which is applicable when drug sponsors seek approval for a new animal drug application.