← FDA GUIDANCE
FDA GUIDANCE · FINALAugust 19, 2026

Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products: Guidance for Industry

What this record is not

Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
Gene Therapy
Issue date
August 19, 2026
CHECKING ACCESS

Checking your Professional access…

READ THE FULL GUIDANCE

The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.

View on fda.gov →

PUT THIS GUIDANCE TO WORK

Decode the standardsThe requirements this guidance interprets →Assess your quality systemBaseline against 12 GxP domains in 10 minutes →All FDA guidanceBrowse the live guidance feed →