Regulatory Support for Cancer Prevention Agent Development
Regulatory Support for Cancer Prevention Agent Development
批准号:
10447553
负责人:
Caroline Sigman
金额:
$282.37万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-09-30 至 2022-09-29
关键词:
Adverse eventAgreementAmendmentAreaChemopreventionChemopreventive AgentClinicalClinical DataClinical ResearchClinical TrialsContractorContractsCooperative Research and Development AgreementDataDevelopmentDisclosureDivision of Cancer PreventionDocumentationInformation ManagementInvestigationLawsMaintenanceMalignant NeoplasmsManagement Information SystemsNational Cancer InstitutePaperPharmacologic SubstancePrevention ProtocolsPrevention programPreventiveProceduresProcessProtocols documentationRecordsRegulationRegulatory AffairsReportingResearchResearch PersonnelSafetyScheduleServicesUnited States Food and Drug Administrationcancer preventionmaterial transfer agreementmeetingspre-clinicalprogramsresearch and development
中文摘要
本合同的目的是为国家癌症研究所(NCI)的癌症预防部门(DCP)提供监管服务和技术支持。本合同将准备和维护美国食品药品监督管理局(FDA)和其他监管机构要求的用于研究药物临床试验的文件。 需要技术支持来收集、解释和总结与潜在癌症预防药物相关的临床前和临床数据。
英文摘要
The purpose of this contract is to provide regulatory services and technical support to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). This contract will prepare and maintain documents required by the Food and Drug Administration (FDA) and other regulatory bodies for clinical trials of investigational agents. Technical Support is required to gather, interpret and summarize the preclinical and clinical data associated with potential cancer preventive agents.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Regulatory Support for Cancer Prevention Agent Development
-
批准号:10676714
-
项目类别:
-
资助金额:$288.94万
-
财政年份:2022
-
负责人:Caroline Sigman
-
依托单位:
Regulatory Support for Cancer Prevention Agent Development
-
批准号:10219786
-
项目类别:
-
资助金额:$276.76万
-
财政年份:2020
-
负责人:Caroline Sigman
-
依托单位:
Regulatory Support for Cancer Prevention Agent Development
-
批准号:10018795
-
项目类别:
-
资助金额:$271.26万
-
财政年份:2019
-
负责人:Caroline Sigman
-
依托单位:
海外基金