FDA Draft Guidance Allows Gene Therapy Companies to Leverage Existing Data for Faster Product Approvals
By
Emily M. Cowley
25d ago· 10 min readenNews
Summary
The FDA released a new draft guidance on June 2 titled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing." This guidance allows gene therapy companies to use existing data from prior work, manufacturing partners, published research, or shared industry databases to support new product applications, rather than requiring them to repeat the same tests. The guidance aims to streamline the development process for gene-editing therapies by reducing redundant testing and accelerating time to market for new treatments.
Source
bskyFDA Draft Guidance Allows Gene Therapy Companies to Leverage Existing Data for Faster Product Approvalsjdsupra.comKey quotes
· 2 pulledThe FDA is telling companies that develop gene-editing therapies: you do not have to start from scratch every time.
If you already have data from your own earlier work, from a manufacturing partner, from published research, or from a shared industry database, the FDA may let you use that data to support a new product instead of running the same tests all over again.
On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene...
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