To help address a number of industry questions, the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance on the submission of initial pediatric study plans (iPSPs) for ...
In a final guidance document, the US Food and Drug Administration provides sponsors with a detailed framework for how to prepare and submit pediatric study plans. The final guidance supplants a draft ...
Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer Legislation to support ...
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