Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval The National Cancer Institute and the Food and Drug Administration (2005) / Chapter Skim
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4 Summary: The Roles of the NCI and the FDA in Developing Anticancer Agents
4 Summary: The Roles of the NCI and the FDA in Developing Anticancer Agents
Pages 54-55
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FDA has been responsible for review and approval of cancer therapeutics in the United States as defined in the statutes reviewed in this background paper, and on its own and at congressional directive has made changes in its procedures and internal structure to improve the efficiency of reviews and approvals and communications to drug and biologics sponsors. For FDA, this has meant: meeting the legal requirements for assessing safety and efficacy of all drugs, including cancer drugs, and for all biologics, including cancer biologics when this responsibility was transferred from NIH; developing evaluative science and the evaluation criteria for cancer drugs and performance goals for reviews and approvals; improving communications and guidance documents for sponsors; developing policies for accelerated approvals and post-marketing confirmatory trials of cancer drugs and appropriate endpoints for cancer trials and approvals; exploring and openly discussing ways of approaching trials, reviews, and approvals of combinations of cancer drugs; thinking through problems and solutions relevant to more precisely molecularly targeted drugs and approaches to cancer and populations with identified 54
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From page 55... ...
Both agencies have issued statements and taken steps to coordinate, collaborate, and cooperate with the objective of ensuring that the potential of recent and projected scientific progress in cancer is translated to new anticancer therapeutics that are less toxic, more specific to precise molecular targets, and more effective in tumor control. NCI and FDA collaborations and continuing work to update procedures and policies for drug identification and development appear to be encouraging directions for the future.
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