martes, 20 de marzo de 2018

FDA' New Pilot Program Aims for More Transparency about New Drug Approvals :: Development & Approval Process (Drugs) > Clinical Data Summary Pilot Program

Development & Approval Process (Drugs) > Clinical Data Summary Pilot Program

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Today the U.S. Food and Drug Administration posted key portions of the Clinical Study Report (CSR) for the pivotal trial of the first drug to participate in the recently announced Clinical Data Summary Pilot.  These portions contain complete summaries of the study results provided by manufacturers, the protocol and protocol amendments, and the statistical plan.  By providing the CSR we hope to:

-Enhance the accuracy of information used in scientific publications;
-Increase stakeholders' understanding of the basis for FDA's approval decisions; and, 
-Inform physicians and other healthcare providers about the detailed results that regulatory decisions were based on.

 Our first pilot participant is Janssen Biotech for the approval of Erleada (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer, as well the first to use the clinical trial result, or endpoint, of metastasis-free survival. Today we posted the CSR of the pivotal study with the regular action package. It’s a novel drug and we believe the CSR information, together with the FDA review, label, and other supporting documents, will facilitate a deeper understanding of how we reached our approval decision.

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