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FDA Proposes Consolidating Manufacturing Information In Applications

 
• By Joanne S. Eglovitch

Combining manufacturing establishment information (MEI) in one electronic form as part of new drug submissions could make review more straightforward and efficient, US agency says.

FDA has proposed that the pharmaceutical industry use one electronic form to submit manufacturing establishment information (MEI) to the agency. Currently this information appears in different places throughout new drug submissions and is confusing to agency reviewers who must sift through applications to find it.

This would apply to manufacturing establishment information (MEI) included in new drug applications, abbreviated new drug applications, biologics license applications,...

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