Gene Therapy: Industry Seeks Greater Clarity In Final FDA CMC Guidance On INDs

 
• By Joanne S. Eglovitch
  
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Industry asks the US FDA to refine the focus of draft guidance on the chemistry, manufacturing and controls information that should go into investigational new drug applications for gene therapies. Questions center on a scope that ranges from CTD to GMP, from in vivo to ex vivo, and from IND to BLA.

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Biopharmaceutical groups say they want greater clarity from the US Food and Drug Administration on the scope of recent draft guidance on chemistry, manufacturing and controls information for gene therapy investigational new drug applications. Industry said that the level of CMC information outlined in the draft is very close to the level required for a biologics license application rather than an IND.

They complain that the 54-page draft document tries to do too much, in the process commingling advice on various development...

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