Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. If you are interested in Beluga caviar, would you think you had adequate opportunity to comment? Would you care if FDA argued that Beluga caviar was high in cholesterol so the two documents were related?
Continue Reading Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development