June 9, 2025
Regulatory News — Stakeholders urge FDA to update CGT regulations to ease path to market for promising therapies
Stakeholders say they want lower regulatory hurdles for cell and gene therapy (CGT) products, including streamlined pathways. Some researchers said updates to the US Food and Drug Administration’s (FDA) platform technology designation and designated advanced manufacturing technology programs hold the most potential to bring promising CGTs to patients. On 5 June, FDA held a roundtable…
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