NOT-MH-05-017: Clarification of IND Requirements for PAR-05-010 – Cooperative Drug Development Group (CDDG) for the Treatment of Mental Illness

Department of Health
and Human Services (HHS)

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Clarification of IND Requirements for PAR-05-010 Cooperative Drug Development Group (CDDG) for the Treatment of Mental Illness

Notice Number: NOT-MH-05-017

Key Dates
Release Date: September 12, 2005

Issued by
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)

The objective of PAR-05-010 (http://grants.nih.gov/grants/guide/pa-files/PAR-05-010.html) is to establish CDDGs to conduct innovative, high impact clinical research focused on the clinical development of IND-ready pharmacological agents targeting novel molecular targets implicated in the pathophysiology of mental illness. To date, applications submitted in response to this announcement have proposed the development of pharmacological agents that are at a very wide range of IND-readiness. In order to standardize review criteria and streamline the award process, the NIMH will now require all applicants to PAR-05-010 to certify within their grant submission that an Investigational New Drug application for the relevant compound has been filed with the FDA and provide the date of the filing. In addition, applicants should be aware that funding to any successful application will be restricted until final IND approval has been obtained from the FDA.

Inquiries

Inquiries regarding this Notice may be directed to:

Wayne S. Fenton, M.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6216, MSC 9621
Bethesda, MD 20892-9621
Telephone: (301) 443-9700
Email: [email protected]

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