Presented February 25, 2014 by Jay Udani, M.D.
Download a PDF of the PPT file for this presentation.
On Jan. 21, the Food and Drug Administration (FDA) reopened a comment period for a controversial guidance that would require an Investigational New Drug (IND) application for clinical research studies of foods and dietary supplements. Currently, an IND is required for drug research, but not for foods and supplement product research.
INDs are utilized for drug research by FDA to determine if the product is “reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development.”
If this guidance were to become law as written, among other things, it would have a chilling effect on innovation and product development, unnecessarily burden research institutions, and create an entirely new set of regulations for industry that are contrary to the current regulatory definitions and intentions for foods and supplements.
In this timely educational session, learn what you need to know about INDs:
Additionally, UNPA President Loren Israelsen will address UNPA’s position on the guidance and its plans to formally respond to FDA during the reopened comment period.