The Regulatory Affairs Branch is composed of the Drug Regulatory Affairs Section and the Agreement Coordination Group. The Drug Regulatory Affairs Section is responsible for the preparation and submission of Investigational New Drug Applications (INDs) to the Food and Drug Administration (FDA) in order to initiate clinical trials with anticancer agents and compliance with all FDA regulatory requirements pertaining to the INDs for these agents. The Coordination Group is responsible for developing, negotiating and implementing research agreements such as Clinical Trials Agreements (CTAs) (MS Word) and Cooperative Research and Development Agreements (CRADAs) (MS Word) for the co-development of investigational anticancer agents with industry collaborators. Confidentiality Agreements (CDAs) (MS Word) and Material Transfer Agreements (MTAs) (MS Word) are also established as appropriate.
RAB consists of the following two areas:
- Drug Regulatory Affairs Section
- Agreement Coordination Group
|
