Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products.
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DOI: 10.1200/jop.2017.023234
Abstract: PURPOSE With the recent use of expedited drug development and approval programs for several oncology products in the United States, the importance of postmarketing plans to confirm clinical benefits and safety is increasing. To discuss… read more here.
Keywords: fda decisions; postmarketing requirements; oncology products; oncology ... See more keywords