Firms Share NDI Notification Tips And Experts Reveal Common Pitfalls (The Tan Sheet)
Early and frequent communication with FDA is key to earning an elusive FDA acceptance of a new dietary ingredient notification on the first try, an agriculture-tech firm executive says.
“In general, regulatory agencies want complete documentation with the first submission. While this isn’t always the case, achieving this goal is nearly impossible without the early interaction,” said Eric Rey, president and CEO of Arcadia Bioscience.
“If you talk to [FDA] first and understand clearly what it is they want, then your ability to put in an application that will address their questions and meet their needs goes up radically. And, therefore, your probability of success goes up radically.”
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Reducing Nitrogen
Usage
Arcadia Biosciences has conducted field trials in five growing seasons. In each field trial, Nitrogen Use Efficiency (NUE) canola demonstrated that it can achieve high yields using significantly less nitrogen fertilizer than conventional varieties. In the chart above, note that NUE canola yielded 2800 lb/ac using two-thirds less nitrogen fertilizer than the conventional variety needed to generate the same yield.
