Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval is an authored background paper describing the federal role in cancer drug development. This report is a part of a project of the National Cancer Policy Board to analyze every aspect of the way new agents to fight cancer are developed and to search for ways to streamline the process. This paper provides useful background detail for those interested in exploring issues that will be informed by how the FDA and NCI act and interact to develop cancer drugs from preclinical research to new drug approval.
Table of Contents
|1 Scientific Rationale||1-6|
|2 The National Cancer Institute||7-27|
|3 The Food and Drug Administration||28-53|
|4 Summary: The Roles of the NCI and the FDA in Developing Anticancer Agents||54-55|
|Acronyms and Abbreviations||61-61|
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