Story perspectives

FDA Eases Rules to Accelerate Cell and Gene Therapies

1/13/2026

Summary

Story summary

The FDA announced plans to ease regulatory requirements for cell and gene therapies (CGTs) to expedite market entry.
The agency aims to amend chemistry, manufacturing, and controls (CMC) in marketing applications to accommodate CGTs.
FDA Commissioner Marty Makary emphasized that these reforms will foster innovation while ensuring safety and quality.
The FDA has approved 50 CGTs, and is developing guidance for regenerative medicines targeting small patient populations.

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Story summary

The FDA announced plans to ease regulatory requirements for cell and gene therapies (CGTs) to expedite market entry.
The agency aims to amend chemistry, manufacturing, and controls (CMC) in marketing applications to accommodate CGTs.
FDA Commissioner Marty Makary emphasized that these reforms will foster innovation while ensuring safety and quality.
The FDA has approved 50 CGTs, and is developing guidance for regenerative medicines targeting small patient populations.