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Literature and Guidance Documents
Regulatory issues in human gene therapy. Blood Cells Mol Dis 2003; 31: 51–56. This paper will review the current oversight agencies and identify areas of evolving regulations that pose particular challenges to gene therapy investigators.
Regulatory issues for clinical gene therapy trials. Hum Gene Ther. 2002; 13(10):1143-9. In this review, the basic tenets of human subject research are discussed in the context of the regulatory bodies which oversee this work. The challenges faced by academic research are outlined, including new and proposed regulations which impact human gene therapy investigators.
NIH Guidelines for Research Involving Recombinant DNA Molecules (September, 2009)
FDA Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events (November 28, 2006)
The Sponsor’s Guide to Regulatory Submissions For an Investigational New Drug. A practical guide for bench Scientists entering the clinical and regulatory realm (March, 2005)
Info US Legislation
Legislation Menu
FDA - CBER News
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What’s New for Biologics
12 April 2024Latest news from the Center for Biologics Evaluation and Research
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FDA Roundup: April 12, 2024
12 April 2024The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Webinar - Breakthrough Devices Program Updated Final Guidance - 11/14/2023
12 April 2024The FDA will host a webinar for industry and other interested stakeholders to discuss the updated final guidance for the Breakthrough Devices Program.
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Coronavirus (COVID-19) | CBER-Regulated Biologics
12 April 2024This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.
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CARVYKTI
12 April 2024For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody