> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Gene Therapy Follow-up Studies
- URL: https://www.fdaweb.com/draft-guide-on-gene-therapy-follow-up-studies/
- Published: 2018-07-13T12:00:00.000Z
- Updated: 2026-09-15T00:19:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141859

*Federal Register* notice: FDA has made available a draft guidance entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products.” The document provides recommendations on the design of long term follow-up observational studies for the collection of data on delayed adverse events following gene therapy administration. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-12/pdf/2018-14867.pdf?ref=fdaweb.com).