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首页> 外文期刊>Avian Diseases >Regulatory Considerations for the Approval of Drugs Against Histomoniasis (Blackhead Disease) in Turkeys, Chickens, and Game Birds in the United States
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Regulatory Considerations for the Approval of Drugs Against Histomoniasis (Blackhead Disease) in Turkeys, Chickens, and Game Birds in the United States

机译：批准美国火鸡，鸡和野禽中的抗组织病（黑头病）药物的监管注意事项

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摘要

Histomoniasis, commonly referred to as blackhead disease, is a serious threat to the turkey and game bird industries worldwide, and it is having an increasingly negative impact on the chicken industry as well. The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM), charged with the approval and regulation of new animal drugs in the United States, understands the rising need for the availability of therapeutic options against histomoniasis. CVM has actively engaged in discussions with the poultry industry, academic institutions, and animal health companies regarding the current status of histomoniasis in the United States and varied success of past and current management, prophylactic, and therapeutic interventions that have been used against the disease. As effective options against the disease are severely limited, CVM encourages the poultry industry, academic institutions, and animal health companies to work together to research and develop viable management, prophylactic, and therapeutic strategies, such as litter management, deworming programs, vaccines or other biologics, novel technologies, and animal drugs. CVM also recognizes the potential challenges that the poultry industry, academic institutions, and animal health companies may encounter while working towards the approval of safe and effective drug products for the treatment and control of histomoniasis. With that recognition, CVM encourages interested parties to begin discussions with CVM early in order to align research of the drug product against histomoniasis with the drug approval requirements, such that it leads to the approval of a new animal drug in an efficient and expedient manner. This article provides information about the FDA's regulatory process for the approval of new animal drugs in the United States, with especial emphasis on drug products for the treatment and control of histomoniasis in turkeys, chickens, and game birds.
机译：组织病，通常被称为黑头病，对全世界的火鸡和野禽业构成严重威胁，并且对鸡肉业的影响也越来越大。食品药品监督管理局（FDA）的兽医医学中心（CVM）在美国负责批准和管理新的动物药物，它了解对针对组织病的治疗选择的日益增长的需求。 CVM积极与家禽业，学术机构和动物保健公司就美国组织病的现状以及过去和当前针对该疾病的管理，预防和治疗干预措施取得的成功进行了积极的讨论。由于严重限制疾病的有效选择，CVM鼓励家禽业，学术机构和动物保健公司共同研究和制定可行的管理，预防和治疗策略，例如垫料管理，驱虫程序，疫苗或其他生物制剂，新技术和动物药物。 CVM还认识到家禽业，学术机构和动物保健公司在努力争取批准用于治疗和控制血友病的安全有效药物产品时可能遇到的潜在挑战。有了这种认可，CVM鼓励感兴趣的各方尽早开始与CVM进行讨论，以使针对抗组织病的药物研究与药物批准要求保持一致，从而使新的动物药物得到有效而便捷的批准。本文提供了有关FDA在美国批准新动物药物的监管程序的信息，特别强调了用于治疗和控制火鸡，鸡和野禽中的组织病的药物。

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