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FDA Continuous Manufacturing Guidance Raises Concerns About Scope And Cost

 
• By Joanne S. Eglovitch

Makers of brand pharmaceuticals focused on scope issues and the definition of terms in their comments on the US FDA's draft continuous manufacturing guidance, while makers of generic drugs raised concerns about cost and lack of benefit.  

ContinuousProduction

The US Food and Drug Administration’s recent draft guidance on continuous manufacturing sparked questions from industry that differed by sector: brand firms wanted to know more about the document's scope; generics firms wanted to know more about how much it would cost them.

The scope questions revolved around matters like whether the document covers only drug substances and not just drug products. Brand...

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