Accelerated Approval for Cancer Drugs in the United States and the Clinical Evidence Required for Conversion to Regular Approval
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DOI: 10.1007/s12247-024-09851-9
Abstract: Oncology products often leverage accelerated approval program to seek earlier launches in the United States. Little is known about how the Food and Drug Administration (FDA) has been balancing evidence and access, and the factors… read more here.
Keywords: oncology; post accelerated; approval requirements; approval ... See more keywords