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US FDA Drops Plan To Simplify Pharmaceutical Plant Reporting

 
• By Bowman Cox

Industry complained draft guidance would have made manufacturing establishment information harder to report, not easier.

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FDA goes back to drawing board on plant reporting • Source: Shutterstock

The US Food and Drug Administration has gone back to the drawing board in its effort to consolidate the electronic submission of pharmaceutical manufacturing facility information after reviewing industry’s concerns about a draft guidance document.

The agency on 22 July withdrew the draft guidance that explained how it planned to implement a provision regarding manufacturing establishment information, or MEI, in drug applications that the FDA Safety and

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