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.

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. Research Abstract Details 

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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. Abstract Text:

BACKGROUND: Cell 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. METHODS: We reviewed letters sent by OCTGT to IND sponsors that were placed on clinical hold. We categorized each deficiency and determined its frequency. RESULTS: We found that similar deficiencies existed across IND applications and we tabulated the most common deficiencies. DISCUSSION: We 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.

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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. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Cytotherapy

VOLUME: 10

Page Numbers: 312-6

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ISSN: 1477-2566

DAY: 17

MONTH: 04

YEAR: 2008

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. Information

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LANGUAGE: eng

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Grant and Affiliation Information for 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.

AFFILIATION: Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland 20852, USA. keith.wonnacott@fda.hhs.gov

Country: England

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MEDLINETA: Cytotherapy

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