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Regulatory Affairs Branch (RAB)
RAB Main
Model Agreements
NCI - Cooperative Group - Industry Relationship Guidelines
Intellectual Property Option Policy
FDA Sites
Databases of Marketed Drugs
IND Application Process
Code of Federal Regulations
FDA Guidances
ICH Guidances
Technology Transfer Sites
Staff, Pictures and Bios
Organizational Chart
CTEP Branches
and Offices
Office of the
Associate Director
Clinical Grants and Contracts Branch
Clinical Investigations Branch
Clinical Trials Monitoring Branch
Investigational
Drug Branch
Pharmaceutical Management Branch
Protocol and Information Office
Regulatory Affairs Branch
Administrative Resource Center
Last Updated:
10/08/08
FDA Guidances
CDER, CBER, ICH Guidances
FDA Guidance for IRBs and Clinical Investigators
Guidance for Good Clinical Practice in FDA-Regulated Clinical Trials
Guidances
Office of Cellular, Tissue and Gene Therapies, CBER, References for the Regulatory Process