FDA eyes collaborative review pilot for gene therapies (From Catapult's regulatory round-up - January 2024)
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9 août 2024
- doi: 10.58079/125n4
info:eu-repo/semantics/openAccess
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The FDA is working on a pilot program that will explore the possibility of concurrent collaborative review of new gene therapy applications with other global regulators. The aim of the pilot is for partners to participate in internal regulatory meetings with sponsors of new gene therapy applications in order to increase the efficiency of the regulatory reviews, reducing the time and the cost for agencies and sponsors to bring these therapies to the market. Please find further information her...