کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2172438 1093542 2008 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: the experience of the Office of Cellular, Tissue and Gene Therapy
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیولوژی سلول
پیش نمایش صفحه اول مقاله
Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: the experience of the Office of Cellular, Tissue and Gene Therapy
چکیده انگلیسی

BackgroundCell and gene therapies are medical products regulated by the U.S. Food and Drug Administration (FDA) within its Center of Biologics Evaluation and Research (CBER) in the Office of Cellular, Tissue, and Gene Therapy (OCTGT). Clinical research using cell and gene therapies in the United States must be conducted under an Investigational New Drug (IND) application. After an initial, 30-day review FDA either places an IND on clinical hold or allows the IND to proceed.MethodsWe reviewed letters sent by OCTGT to IND sponsors that were placed on clinical hold. We categorized each deficiency and determined its frequency.ResultsWe found that similar deficiencies existed across IND applications and we tabulated the most common deficiencies.DiscussionWe discussed the deficiencies and the resources that can help individuals avoid those deficiencies. We believe that awareness of the common deficiencies along with the applicable resources can reduce the frequency of clinical holds and allow clinical studies to proceed without delay. We also believe that this information will guide the FDA as to how to facilitate development of safe and effective cell and gene therapies.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Cytotherapy - Volume 10, Issue 3, 2008, Pages 312–316
نویسندگان
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