# Center for Biologics Evaluation and Research (CBER)

Type: organization

Source: Legal & RegTech Intelligence Brief — https://getlegalbrief.com/entity/center-for-biologics-evaluation-and-research-cber-organization
Canonical HTML page: https://getlegalbrief.com/entity/center-for-biologics-evaluation-and-research-cber-organization

## Timeline

- **2026-02-23**: Expedited Pathway Formalized — FDA announces the formal implementation of quicker paths for gene therapy via surrogate endpoints.
- **2024-05-15**: START Pilot Launch — FDA initiates a pilot program for Support for clinical Trials Advancing Rare disease Therapeutics.
- **2023-03-01**: CBER Reorganization — The Office of Tissues and Advanced Therapies is elevated to a 'Super Office' to handle CGT volume.
- **2017-12-19**: Luxturna Approval — FDA approves the first gene therapy for an inherited disease, setting the initial regulatory precedent.

## Recent coverage (1 stories)

### FDA Accelerates Gene Therapy Approvals via New Regulatory Framework
2026-02-23 22:35:23 · Sentiment: Positive · Impact: 8/10 · Sources: 8

The U.S. Food and Drug Administration has established a streamlined regulatory pathway to expedite the development and review of gene therapies. This initiative focuses on leveraging surrogate endpoints and platform technologies to bring life-altering treatments for rare diseases to market faster.
Full story: https://getlegalbrief.com/story/fda-expedited-gene-therapy-pathway

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