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# FDA’s Gene Therapy Regulatory Role
- URL: https://www.fdaweb.com/fdas-gene-therapy-regulatory-role/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:13.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138051

A new National Academies book, *Human Genome Editing: Science, Ethics, and Governance*, says that FDA is one of several agencies and organizations that have a significant role in regulating both somatic and germline human genome editing. The [publication](https://www.nap.edu/login.php?record%5Fid=24623&page=https%3A%2F%2Fwww.nap.edu%2Fdownload%2F24623&ref=fdaweb.com) says that human genome therapies are considered to be gene therapies with regard to FDA oversight, and the agency regulates human genome editing under the existing framework for biological products, which includes gene therapy products.

FDA has authorized some gene therapy trials, according to the book, but has not yet approved a gene therapy for market. If one is approved, it says, it will still be subject to FDA’s ongoing monitoring and, if necessary, restrictions on its use. “This FDA oversight entails review under rules governing biologics and, in many cases, under rules governing drugs,” it says.

Once gene therapies are introduced into clinical care, the book adds, not only will FDA maintain surveillance to detect safety concerns, but formal studies of the labeled uses also may be conducted to take a fresh look at the therapy’s safety and efficacy.