RADIATION/NUCLEAR MEDICAL COUNTERMEASURE (MCM) PRODUCT DEVELOPMENT SUPPORT SERVICES. TASK ORDER B-1, ANIMAL MODEL DEVELOPMENT AND INITIAL EFFICACY TESTING OF CANDIDATE MCMS.

辐射/核医疗对策 (MCM) 产品开发支持服务。

• 批准号: 9153304
• 负责人: POLLY CHANG
• 金额: $ 624.53万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9153304
• 关键词: Award; Clinical; Contract Services; Contracts; Documentation; Drug Formulations; Evaluation; Human; Licensing; Medical; Medical Licensure; National Institute of Allergy and Infectious Disease; Nuclear; Pharmacology; Radiation; Radiation Injuries; Research; Safety; Services; Strategic Planning; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; animal efficacy; animal model development; authority; efficacy testing; good laboratory practice; product development; research and development; stability testing

The Department of Health and Human Services has assigned the NIH the responsibility to identify, characterize, and develop new medical countermeasures (MCM) against radiological or nuclear threats. As part of the “NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats”, the NIAID awarded the Medical Countermeasures against Radiological Threats: Product Development Support Services contract to provide support services for products that may have the potential to become radiation or nuclear medical countermeasures. This contract is tasked with bringing these potential countermeasures to a point at which they can 1) be approved or licensed by the U.S. Food and Drug Administration (FDA) or 2) transition to the Biomedical Advanced Research and Development Authority (BARDA). When approved, these MCMs could be acquired by the Strategic National Stockpile.

卫生与公共服务部已将NIH责任确定，表征和开发针对放射线或核威胁的新医学对策（MCM）。作为“ NIH战略计划和针对放射学和核威胁的医学对策”的一部分，NIAID授予了针对放射性威胁的医学对策：产品开发支持服务服务合同，为可能有可能成为辐射或核医疗对策的产品提供支持服务。该合同的任务是将这些潜在的对策提升到可以1）获得美国食品和药物管理局（FDA）或2）过渡到生物医学高级研发局（BARDA）的批准或许可的地步。经过批准后，这些MCM可以由战略国家库存获得。