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Major Medical, Scientific, and Food Associations Object to FDA IND Guidance

A. Wes Siegner
Hyman, Phelps & McNamara, P.C. - Washington Office

February 27, 2014

Previously published on February 26, 2014

The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA has now done:

  • American Academy of Pediatrics
  • American Society for Nutrition
  • American Society for Parenteral and Enteral Nutrition
  • Institute of Food Technologists
  • International Life Sciences Institute North America
  • International Scientific Association for Probiotics and Prebiotics
  • North American Society for Pediatric Gastroenterology, Hepatology and Nutrition

We have previously posted on this guidance, its implications for foods, medical foods, and cosmetics, and FDA’s decision to reopen the comment period for this guidance. Comments are due April 9, 2014.


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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