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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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Health Fraud Scams
23 April 2024Learn how to spot health fraud and avoid it.
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Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
23 April 2024Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, CBER, Biiologics
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Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
23 April 2024Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, final, vaccines
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FDA Roundup: April 23, 2024
23 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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Drugs@FDA Data Files
23 April 2024Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)