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FDA eyes collaborative review pilot for gene therapies (From Catapult’s regulatory round-up – January 2024)

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 here.

News Published on the 6th of february 2024. Read the entire regulatory round-up for January following this link.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (9 août 2024). FDA eyes collaborative review pilot for gene therapies (From Catapult’s regulatory round-up – January 2024). ELSIBI. Consulté le 11 janvier 2026 à l’adresse https://doi.org/10.58079/125n4


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