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.

The present study was carried out to evaluate the pathological effects of aspergillosis caused by Aspergillus Spp. in commercial broiler chickens. In this study, we discussed few outbreaks of Aspergillus infection of chicks a week aftter hatching in broiler farms of Duhok-Kurdistan region of Iraq during the period from February to May 2015 on the basis of clinical signs, post-mortem, histopathological and cultural findings. The main clinical signs of the disease in the infected flock included a 3-day onset of labored breathing and neurologic disorders displayed by incoordination, torticollis, and paralysis. Other clinical features included depression, ruffled feathers and gasping. Gross lesions were represented by cheesy granular materials in the air sacs, lungs, and trachea. Histopathology revealed fungal hyphae in sectioned lung tissue. Aspergillus was isolated by culturing in Sabouraud's dextrose agar from the lesions. The present study deals with the incidence of acute aspergillosis in broiler chicks from Duhok, Kurdistan-Iraq.