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U.S. Department of Health and Human Services

About FDA

OCTGT Reviewer Tools

Description: 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. Information is current as of September 30, 2012.

Accomplishment: 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.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

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

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.