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

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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.