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National Institute on Drug Abuse

Division of Treatment Research and Development

RAB - Branch Functions


Regulatory Affairs Branch
  1. To provide technical and administrative leadership to DTR&D's effort in recruiting industry and other development partners, acquiring new testing compounds; to identify barriers and propose development strategies.

  2. To maintain contact with the U.S. Food and Drug Administration (FDA) to lead the filing of Investigational New Drug (IND) applications, and New Drug Applications (NDA) as new medications enter or complete clinical studies.

  3. To provide consultation and advice on nonclinical and clinical medication development requirements and strategy to NIDA grantees, contractors, and other interested parties regarding projects of mutual interest.

  4. To provide guidance and support to potential development partners, including developing and negotiating Cooperative Research and Development Agreements, Material Transfer Agreements, and interagency agreements with other federal agencies.

  5. To lead DTR&D patent and technology transfer activities through contacts with Offices of the General Counsel, Office of the Secretary (HHS), and the NIH Office of Technology Transfer.


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National Institutes of Health logo_Department of Health and Human Services Logo The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH) , a component of the U.S. Department of Health and Human Services. Questions? See our Contact Information. Last updated on Monday, January 22, 2001. The U.S. government's official web portal