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US FDA Adds Shorter NDIN 'Burdens' In 'Program Change,' 'Submissions' Estimate Unchanged

 
• By Malcolm Spicer

FDA Office of Dietary Supplement Programs still predicts 20 hours are needed for submitting each of the 55 NDINs it expects to receive but adds 5 hours for all 55 for manufacturing process and identity information and 1 hour for identity specifications in table form. Also adds 1 hour for estimated 1 NDIN for administrative procedures list form and template; and 24 minutes for expected 10 for master files written authority.

• Source: Shutterstock

The US Food and Drug Administration references one of its pending draft guidances for new dietary ingredient notifications in adding blocks of 6 hours, 1 hour or roughly half an hour to its estimates for the time needed to submit a notification.

In a recent Federal Register notice for comments on its estimates before submitting the document for Office of Management...

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