REGULATORY AFFAIRS SUPPORT. SEPTEMBER 22, 2017 - SEPTEMBER 21, 2022. N01DA-17-8933.

NIDA治疗和医学后果部门(DTMC)努力加快新化合物被识别、评估、开发和批准为治疗药物滥用和成瘾的新药的速度。因此，潜在有用的化合物是从商业、政府和学术来源获得的。根据它们的临床前和临床发展阶段对这些化合物进行评估。该计划寻求开发新的 治疗药物滥用症状和疾病的药物治疗药物，包括以下药物： A.实现禁欲； B.阻止滥用药物的影响； C.减少对滥用药物的渴望； 缓解或消除戒断症状； E.阻止或逆转滥用药物的毒性影响；以及 F.防止吸毒戒毒者复发。 这份合同将通过准备向食品和药物管理局(FDA)提交的监管文件来为DTMC提供研究支持。这些申请将包括初步研究新药申请(IND)、新药申请(NOA)和补充NOA(SNDA)申请、年度报告、议定书修正案、信息修正案和特别文件。

The NIDA Division of Therapeutics and Medical Consequences (DTMC) strives to accelerate the speed with which new compounds are identified, evaluated, developed and approved as new medications to treat drug abuse and addiction. Therefore, potentially useful compounds are solicited from commercial, government and academic sources. These compounds are evaluated based on their stage of preclinical and clinical development. The program seeks to develop new pharmacotherapeutic medications to treat the symptoms and disease of drug abuse, including medications to: a. achieve abstinence; b. block the effects of abused drugs; c. reduce the craving for abused drugs; d. moderate or eliminate withdrawal symptoms; e. block or reverse the toxic effects of abused drugs; and f. prevent relapse in persons detoxified from drugs of abuse. This contract will provide research support to DTMC by preparing regulatory submissions for filing with the Food and Drug Administration (FDA). These submissions will consist of Initial lnvestigational New Drug (IND) applications, New Drug Application (NOA) and supplemental NOA (sNDA) submissions, annual reports, protocol amendments, information amendments, and Ad Hoc documents.