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# Guide on Gene Therapy Observational Studies
- URL: https://www.fdaweb.com/guide-on-gene-therapy-observational-studies/
- Published: 2020-01-31T12:00:00.000Z
- Updated: 2026-09-14T16:01:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145980

*Federal Register* notice: FDA has made available a final guidance entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products.” The document provides recommendations on designing long-term follow-up observational studies for collecting data on delayed adverse events following gene therapy administration. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-30/pdf/2020-01710.pdf?ref=fdaweb.com).