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Investigational New Drug - Springer Nature

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Last Updated: 06 February 2022

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Investigational New Drug Applications for Cell Therapy Products

The Food and Drug Administration and at least one Institutional Review Board are required to review clinical trials in the United States that use cellular therapy products. In addition, if the cellular product contains a gene transfer component, the trial will also require review by at least one Institutional Biosafety Committee. Failure to obtain adequate regulatory oversight of clinical trials can have serious ramifications, including reduction of funding, inability to publish, and limitations in the ability to pursue additional clinical research. This chapter discusses the procedure for submitting an Investigational New Drug application to the FDA.

Source link: https://doi.org/10.1007/978-3-030-75537-9_7


Regulatory Framework for Academic Investigator-Sponsored Investigational New Drug Development of Cell and Gene Therapies in the USA

Purpose of Review by The United States Food and Drug Administration The promise of cell and gene therapy products for a variety of illnesses has reignited researchers' efforts to advance novel CGT product candidates to first-in-human trials by investigating the experimental new drug technology used by the US Food and Drug Administration. The latest findings indicate that CGT products are extremely complex biologics, and, as a result, early-stage evaluation services must be tailored to satisfactorily solve their specific developmental challenges. The US FDA continues to promote the creation of transformal technology that can enable the widespread introduction of safe and effective gene therapy drugs that have the ability to treat numerous conditions that were previously out of reach of therapeutic intervention. Summary The pathway to achieve regulatory compliance within early stage IND programs can be daunting to academic investigators interested in CGT product development, which rarely progress beyond phase 1.

Source link: https://doi.org/10.1007/s40778-021-00196-4

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions