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United States Food and Drug Administration Drug Approval Summary
Clinical Cancer Research, 2004Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Martin H. Cohen +11 more
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Oncology drug development: United States Food and Drug Administration perspective
Critical Reviews in Oncology/Hematology, 2002The Food and Drug Administration (FDA) in the United States has multiple roles. The primary responsibilities for oncology drug products are the supervision of clinical research, the evaluation of marketing claims for new and previously approved drugs, the granting of exclusive marketing licenses for approved claims, and the monitoring of post-marketing
Steven, Hirschfeld, Richard, Pazdur
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End Points and United States Food and Drug Administration Approval of Oncology Drugs
Journal of Clinical Oncology, 2003Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002.
John R, Johnson +2 more
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