title: Regulatory Considerations for the Approval of Drugs Against Histomoniasis (Blackhead Disease) in Turkeys, Chickens, and Game Birds in the United States.
abstract: 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.
authors.affiliation: A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Prajwal R
authors.initials: PR
authors.lastname: Regmi
authors.affiliation: A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Ashley L
authors.initials: AL
authors.lastname: Shaw
authors.affiliation: A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Laura L
authors.initials: LL
authors.lastname: Hungerford
authors.affiliation: A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Janis R
authors.initials: JR
authors.lastname: Messenheimer
authors.affiliation: A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Tong
authors.initials: T
authors.lastname: Zhou
authors.affiliation: B Office of Surveillance and Compliance, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Padmakumar
authors.initials: P
authors.lastname: Pillai
authors.affiliation: C Office of Minor Use and Minor Species, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Amy
authors.initials: A
authors.lastname: Omer
authors.affiliation: A Office of New Animal Drug Evaluation, Center for Veterinary Medicine, United States Food and Drug Administration, Rockville, MD 20855.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Gilbert
mesh_terms: D000818:Animals; D002645:Chickens; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D011201:Poultry Diseases / Q000188:drug therapy* / Q000469:parasitology; D011528:Protozoan Infections / Q000188:drug therapy* / Q000469:parasitology; D014422:Turkeys; D014481:United States; D014486:United States Food and Drug Administration; D019155:Veterinary Drugs / Q000627:therapeutic use; D014730:Veterinary Medicine / Q000458:organization & administration
chemical_list: D019155:Veterinary Drugs
keywords: FDA; Histomonas meleagridis; blackhead disease; chicken; drug approval; game bird; histomoniasis; treatment and control; turkey