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# Stakeholders Seek Changes in CAR-T Draft Guidance
- URL: https://www.fdaweb.com/stakeholders-seek-changes-in-car-t-draft-guidance/
- Published: 2022-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:48:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152092

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes the recommendations in an FDA draft guidance on considerations for developing chimeric antigen receptor (CAR) T cell products “are essential in helping sponsors navigate development issues in this rapidly evolving field.” In a 6/14 comment [letter](https://www.regulations.gov/comment/FDA-2021-D-0404-0078?ref=fdaweb.com), PhRMA says that in recognition of the complexity and quickly evolving use of this technology, FDA should periodically assess various technologies related to CAR-T development and update the guidance accordingly. PhRMA also lists other guidance topic areas where it says additional clarifications would be helpful.

The International Society for Pharmaceutical Engineering [recommends](https://www.regulations.gov/comment/FDA-2021-D-0404-0058?ref=fdaweb.com) that FDA add **(1)** a reference to quality by design, **(2)** additional visual representations/diagrams for CAR-T construct, **(3)** patient population demographic considerations, **(4)** limitations of CAR-T cell therapy, **(5)** key considerations for setting and determining appropriate trial endpoints, and **(6)** quality considerations for pre-clinical through late-stage development.

In its [letter](https://www.regulations.gov/comment/FDA-2021-D-0404-0070?ref=fdaweb.com), Novartis says sponsors must engage with FDA early and often to ensure they are aligned on how best to develop the new therapies. “Current meeting types, including PDUFA meetings, are not an efficient means to seek FDA feedback,” the company says. “Communication opportunities outside of PDUFA meetings are needed.”

Novartis also suggests changes and clarifications for sections on chemistry, manufacturing, and controls (CMC); non-clinical studies; clinical studies; and long-term follow-up.

AstraZeneca [recommends](https://www.regulations.gov/comment/FDA-2021-D-0404-0051?ref=fdaweb.com) changes in three sections of the draft — CMC; pre-clinical; and clinical dosing.

Finally, Gilead’s Kite subsidiary [says](https://www.regulations.gov/comment/FDA-2021-D-0404-0052?ref=fdaweb.com) FDA should consider providing more specific guidance on the stage-appropriate CMC information for submission, including examples.

All five stakeholders also provided line-by-line specific comments.