Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · Feb 2010
ReviewReview of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
The Office of Oncology Drug Products (OODP) in the Center for Drug Evaluation and Research at the US Food and Drug Administration began reviewing marketing applications for oncological and hematologic indications in July 2005. We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007. ⋯ During the study period, regulatory action was taken on 58 of the 60 marketing applications. Fifty-three applications were approved. A variety of clinical trial endpoints were used in the approval trials.
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J. Natl. Cancer Inst. · Feb 2010
ReviewDuctal carcinoma in situ of the breast: a systematic review of incidence, treatment, and outcomes.
The National Institutes of Health Office of Medical Applications of Research commissioned a structured literature review on the incidence, treatment, and outcomes of ductal carcinoma in situ (DCIS) as a background article for the State of the Science Conference on Diagnosis and Management of DCIS. ⋯ Scientific questions deserving further investigation include the relationship between mammography use and DCIS incidence and whether imaging technologies and treatment guidelines can be modified to focus on lesions that are most likely to become clinically problematic.