FDA Proposes New Guidelines to Accelerate Cell, Gene, and Rare Disease Therapies
TL;DR Summary
The FDA's biologics center has released new draft guidances aimed at helping developers streamline the creation of innovative cell and gene therapies for small patient populations.
- FDA unveils trio of new draft guidances to help cell and gene therapy developers Endpoints News
- Rare Disease Experts See Futility in FDA’s Proposed Framework BioSpace
- FDA Introduces Guidance to Expedite Rare Disease Drug Approvals Bloomberg Law News
- FDA Announces Rare Disease Evidence Principles to Accelerate Treatments for Ultra-Rare Genetic Diseases Wilson Sonsini
- FDA Mulling Existing Data Types Sponsors May Leverage to Speed Cell, Gene Therapies to Market Precision Medicine Online
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