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Gene Therapies: CoGenT Pilot Could Help With Regulatory Convergence Earlier In Development

 
• By Sue Sutter

The program for collaborative gene therapy reviews with the European Medicines Agency is starting with simple applications, but after launch could be expanded to earlier discussions of CMC and pharm/tox data requirements, the FDA’s Nicole Verdun said.

Plane taking off
The FDA/EMA CoGenT Pilot program for gene therapies is taking flight. • Source: Shutterstock

The US Food and Drug Administration’s global pilot program to promote regulatory convergence for gene therapies is only just beginning, but the agency already is eyeing a future expansion of its reach to earlier in the product development lifecycle.

The Collaboration on Gene Therapies (CoGenT) Global Pilot is an initiative to explore the potential for concurrent submission and collaborative review of gene therapy applications with international regulatory partners.

Key Takeaways

  • The FDA and EMA are launching the CoGenT Global Pilot to promote regulatory convergence for gene therapy applications.

  • Although the pilot initially will focus...

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