CCR Perspectives in Drug Approval
نویسندگان
چکیده
Recent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated Approval and Breakthrough Therapy Designation hold the promise of making new treatments available sooner through the use of smaller studies using intermediate endpoints. Here, we consider the inherent limitations of smaller studies and discuss the strategies for hastening oncology drug development while maintaining high-efficacy standards. Clin Cancer Res; 19(16); 4305–8. 2013
منابع مشابه
Introducing CCR perspectives in drug approval.
In this issue of Clinical Cancer Research, we are pleased to introduce a new feature titled CCR Perspectives in Drug Approval. This feature will incorporate the popular Report from the FDA but will evolve to include perspectives from other regulatory groups addressing broad topics that affect the drug approval process, as well as discussions of how national regulatory bodies are approaching the...
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