# Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/interpreting-sameness-of-gene-therapy-products-under-the-orphan-drug-regulations-guidance-for-industry/d27ec8e3-b338-46f1-8b89-72ee766cf16c

> FDA guidance document: Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations:  Guidance for Industry. Issue date: September 29, 2021. Get complete insights and analysis.

---

## Details

- Title: Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2021-09-29
- Comment Close Date: 2020-07-28
- Last Changed: 2022-03-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-5392 ">FDA-2019-D-5392 </a>

## Related Documents

- [Human Gene Therapy for Rare Diseases:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/human-gene-therapy-for-rare-diseases-guidance-for-industry/1cebc8e2-7d3b-4c5f-a4c4-78d1fc112099)
- [Long Term Follow-up After Administration of Human Gene Therapy Products:   Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/long-term-follow-up-after-administration-of-human-gene-therapy-products-guidance-for-industry/5f3e0db9-8c8a-45b5-864f-6250a3250b1b)
- [Human Gene Therapy for Hemophilia:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/human-gene-therapy-for-hemophilia-guidance-for-industry/bceafce9-c9f0-4137-9ca5-071464212a06)