Develop reviewer tools to improve the management and review efficiency of tracking and reporting of long-term follow-up safety data for clinical studies using gene therapy products, and to increase review process efficiency by decreasing the timelines needed for preparing sponsor-meeting minutes, review memorandums for regulatory applications and issuing regulatory letters. Public Health Outcome: The reviewer tools will increase review process efficiency for cell and gene therapy products and biologic related devices and may further enhance the safety of gene therapy products. <i>Information is current as of September 30, 2012</i>. As a result of the development and implementation of the OCTGT reviewer tools (for tracking and reporting of long-term follow-up safety data for clinical studies using gene therapy products) and OCTGT review practices and timeline reference guide, OCTGT has been able to reassess and incorporate changes to its internal review process. These changes have resulted in an increase in OCTGT’s review process efficiency for preparing sponsor-meeting minutes, reviewing memorandums and issuing regulatory letters for cell and gene therapy biologic products and devices. Also, these changes have greatly enhanced the safety reporting of gene therapy products used in clinical studies. A. Implement final working draft of OCTGT Review Practices and Timeline Reference Guide 6/30/2011 Completed 6/15/2011 B. Implement final working draft of OCTGT Process for Review of Long-Term Follow-Up (LTFU) Data for Clinical Studies Using Gene Therapy Products Guide 7/31/2011 Completed 7/20/2011 C. Conduct assessment of OCTGT Review Practices and Timeline Reference Guide after 6 months of use to determine compliance and re-evaluate procedures 1/31/2012 Completed 1/26/2012 D. Issue revised OCTGT Review Practices and Timeline Reference Guide 3/1/2012 Completed 2/16/2012 E. Conduct assessment of OCTGT Process for Review of LTFU Data for Clinical Studies Using Gene Therapy Products Guide after 12 months of use to determine compliance and re-evaluate procedures 8/31/2012 Completed 8/31/2012 F. Issue revised OCTGT Process for Review of LTFU Data for Clinical Studies Using Gene Therapy Products Guide 11/30/2012 Completed 11/19/2012 Molecular Epidemiology Molecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations. http://www.fda.gov/AboutFDA/Transparency/track/ucm206349.htm#KeyProject FDA-TRACK CBER Research and Review Offices Dashboard ਍††਍਍਍਍਍਍਍