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raps·1d ago·1 min read
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Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance

Aug 20, 2026·read at raps ↗RegulatoryNeutral

The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations for these emerging treatments.

President Donald Trump announced that White House aide Heidi Overton will become the next FDA Commissioner, succeeding Marty Makary who left the agency in May. The announcement was posted on Trump’s Truth Social account on August 19.

Overton’s nomination must be confirmed by the Senate, and her appointment comes as the FDA continues to shape policy for advanced therapies.

source

This writeup was produced by pharmadog from original reporting by raps.

Original headline: “FDA finalizes Q&A guidance on developing cell and gene therapies”

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