Regmi Prajwal R, Shaw Ashley L, Hungerford Laura L, Messenheimer Janis R, Zhou Tong, Pillai Padmakumar, Omer Amy, Gilbert Jeffrey M
A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
B Office of Surveillance and Compliance, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
Avian Dis. 2016 Dec;60(4):725-730. doi: 10.1637/11451-061516-Review.1.
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.
组织滴虫病，通常被称为黑头病，对全球火鸡和珍禽养殖业构成严重威胁，对养鸡业的负面影响也日益增大。美国食品药品监督管理局（FDA）的兽药中心（CVM）负责美国新动物药品的审批和监管，深知对抗组织滴虫病的治疗方案需求日益增长。CVM已积极与家禽业、学术机构及动物健康公司就美国组织滴虫病的现状以及过去和当前用于防治该疾病的管理、预防和治疗干预措施的不同成效展开讨论。由于对抗该疾病的有效方案极为有限，CVM鼓励家禽业、学术机构及动物健康公司携手合作，研究并开发可行的管理、预防和治疗策略，如垫料管理、驱虫计划、疫苗或其他生物制品、新技术以及动物药品。CVM也认识到家禽业、学术机构及动物健康公司在致力于获批用于治疗和控制组织滴虫病的安全有效药品时可能遇到的潜在挑战。有了这一认识，CVM鼓励相关方尽早与CVM展开讨论，以便使针对组织滴虫病的药品研究符合药品审批要求，从而高效快捷地获批新动物药品。本文提供了有关美国FDA审批新动物药品的监管流程的信息，特别着重于用于治疗和控制火鸡、鸡及珍禽组织滴虫病的药品。
