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When Seeking ‘Breakthrough’ Status, Beware Of Manufacturing Changes

 
• By Sue Sutter

Clinical data supporting a designation request should come from a product under development, not from a study using an earlier formulation, CBER reps say. Rolling submissions help ensure that potential manufacturing and facility concerns are identified early.

Manufacturing considerations can impact FDA’s decision on whether a product deserves “breakthrough therapy” status as well as approval time under the expedited regulatory pathway.

Changes in the manufacturing process during development, particularly with a complex biologic, can make it difficult to assess whether early efficacy results will be replicated when the product is made...

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