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How To Show The US FDA You’ll Be Marketing The Same Cell And Gene Therapies You Trialed

 
• By Bowman Cox

With characterization of cell and gene therapies still in its infancy, the FDA shares advice on how to demonstrate comparability between the versions manufactured for clinical trials and the versions to be produced for commercial use. Starting earlier with scalable manufacturing processes helps. Limited additional clinical studies may be needed in some cases.

Are they the same?
are they the same or not? here's how to tell • Source: Shutterstock

There are ways to reduce the possibility that changes in the manufacture of cell and gene therapies firms are developing will lead to regulatory delays, and the US Food and Drug Administration describes some of them in draft guidance issued 14 July.

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EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 
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Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
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