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Published 2 days ago • loading... • Updated 2 days ago

CDER and CBER offer new submission program for rare disease gene therapies

Summary by endpoints.news

The FDA’s drug and biologics centers on Wednesday jointly proposed a new process for facilitating the approval of therapies that could treat exceptionally rare diseases, formalizing what had been in the works since the days of former CBER Director Peter Marks.

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1 Articles

1 Articles

CDER and CBER offer new submission program for rare disease gene therapies

The FDA’s drug and biologics centers on Wednesday jointly proposed a new process for facilitating the approval of therapies that could treat exceptionally rare diseases, formalizing what had been in the works since the days of former CBER Director Peter Marks.

2 days ago

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endpoints.news broke the news in 2 days ago on Wednesday, September 3, 2025.

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