Challenges and Benefits of Repurposing Licensed/Approved/Cleared Products for a Radiation Indication.
Radiat Res
; 190(6): 654-658, 2018 12.
Article
em En
| MEDLINE
| ID: mdl-30281977
ABSTRACT
Increasingly, the risk of a radiological or nuclear public health emergency is a major concern for the U.S. government. To address a potential incident and ensure that the U.S. Government is prepared to respond to any civilian or military casualties that could result, the U.S. Department of Health and Human Services (HHS), together with the Department of Defense, has been charged with the development of medical countermeasures (MCMs) to treat individuals experiencing acute and delayed injuries that can result from exposure to radiation. With limited research and development budgets, and the high costs associated with bringing promising approaches from the bench through advanced product development activities, and ultimately, to regulatory approval, the U.S. Government places a priority on repurposing drugs that have already been commercialized for other indications in humans. To address the benefits and challenges of repurposing licensed products for a radiation indication, the National Institute of Allergy and Infectious Diseases convened a workshop with participants from U.S. Government agencies and industry, as well as academic subject matter experts. Topics included U.S. Government efforts (e.g., funding, regulatory, stockpiling and innovative ways to make drugs available for study), as well as the unique regulatory and other challenges faced when repurposing branded or generic drugs.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Lesões por Radiação
/
Liberação Nociva de Radioativos
/
Emergências
/
Reposicionamento de Medicamentos
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Radiat Res
Ano de publicação:
2018
Tipo de documento:
Article