Peer-reviewed veterinary case report
Regulatory Considerations for the Approval of Drugs Against Histomoniasis (Blackhead Disease) in Turkeys, Chickens, and Game Birds in the United States.
- Journal:
- Avian diseases
- Year:
- 2016
- Authors:
- Regmi, Prajwal R et al.
- Affiliation:
- A Office of New Animal Drug Evaluation · United States
- Species:
- bird
Plain-English summary
Histomoniasis, also known as blackhead disease, is a serious illness affecting turkeys, chickens, and game birds, and it poses a growing threat to these industries. The FDA's Center for Veterinary Medicine is aware of the urgent need for effective treatments and is actively working with poultry producers, researchers, and animal health companies to find solutions. They are encouraging collaboration to develop various strategies, including better management practices, deworming, vaccines, and new medications. The FDA also acknowledges that there may be challenges in getting new drugs approved and suggests that those interested in developing treatments start discussions early to ensure their research aligns with approval requirements. Overall, the article outlines the FDA's process for approving new drugs specifically aimed at treating histomoniasis in these bird species.
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.
Find similar cases for your pet
PetCaseFinder finds other peer-reviewed reports of pets with the same symptoms, plus a plain-English summary of what was tried across them.
Search related cases →Original publication: https://pubmed.ncbi.nlm.nih.gov/27902913/