www.fdanews.com/articles/179911-draft-guidance-will-streamline-submissions-of-manufacturing-establishment-information
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Draft Guidance Will Streamline Submissions of Manufacturing Establishment Information
January 5, 2017
Submissions of manufacturing establishment information (MEI) by manufacturers are about to be changed. A new FDA draft guidance has been published outlining the requirements and implementation regarding valid electronic submission of MEIs.
The guidance allows drugmakers to streamline required information on the manufacturing establishments.
Additionally, the consolidation effort will help eliminate potentially outdated and erroneous information that are sometimes retrieved from other agency files.