This project provides administrative, technical, informatics and regulatory resources and expertise to support the regulatory affairs functions for the Division of Cancer Prevention (DCP) chemopreventive agent development program. The regulatory contactor develops and implements procedures for accessing, reviewing, and compiling scientific, safety, and clinical data for possible inclusion in lNDs and other regulatory submissions. Regulatory submissions are made in accordance with FDA regulations, ICH (International Committee on Harmonization) guidelines, and NIH, NCI, and DCP requirements and other relevant regulations, laws, and guidelines. Primarily this task involves the preparation and submission of Investigational New Drug Applications (INDs) to the U.S. Food and Drug Administration. Submissions will also include Drug Master Files (DMFs), New Drug Applications (NDAs), providing adverse event data for development of the Investigator's Brochures by the Technical Support contractor, Common Technical Documents, and other documents required by FDA regulations. For multinational research efforts supported by DCP, the contractor may be directed to prepare submissions to international regulatory bodies.

Agency
National Institute of Health (NIH)
Type
Research and Development Contracts (N01)
Project #
261201100064C-4-0-1
Application #
8737159
Study Section
Project Start
2011-09-30
Project End
2014-09-29
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$2,010,678
Indirect Cost
Name
Ccs Associates Inc
Department
Type
DUNS #
602744732
City
Mountain View
State
CA
Country
United States
Zip Code
94043