IPP - DRUG DEVELOPMENT SUPPORT FOR CTEP

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The “Drug Development Support for the CTEP” contract provides support to the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) for a spectrum of support services. The main objective of this contract is to provide a technical and administrative infrastructure to support FDA regulatory sponsor compliance, to fulfill the terms of pharmaceutical collaborator agreements and to assist in the solicitation of clinical trials. The support tasks include: 1) the preparation, tracking, submission and distribution of CTEP drug development related documents and FDA submissions; 2) tracking information regarding investigational anti-cancer agents including biomarkers; 3) support safety monitoring and adverse event reporting; 4) support collaborator agreement activities and 5) provide general technical and administrative support for investigational agent development and regulatory activities.