date:Jul 19, 2012
ified) neural, brain or psychological functions in general are not sufficiently defined for a scientific evaluation.
Normal development claims were also considered insufficiently defined, in a guidance that also confirmed the agencys well-known preference for human, intervention trials above other forms of evidence like animal andin vitroresearch.
The guidance, while not unexpected as it follows from the general thrust of NDA claim opinions issued since 2008, will not please many nutrient supp