In re: FDA Expansion of IND Requirements
- Case Date: 4/8/2014
- Project Name: Health Care Project
On April 8, 2014, WLF filed formal comments with FDA, urging it to rescind a recently released guidance document that asserts agency approval rights over virtually all human research studies performed in the United States. WLF argued that FDA lacks statutory authority to require that researchers obtain FDA approval of an IND (investigation new drug) application before undertaking a study. WLF stated that FDA’s IND authority extends only to clinical research involving “investigational drugs” and generally does not extend to food, dietary supplements, and cosmetics, as FDA is now asserting. WLF stated that preparing and submitting an IND can be quite expensive and thus that subjecting clinical studies of food to IND requirements could render them prohibitively expensive. WLF also faulted FDA for adopting the guidance document in violation of the Administrative Procedure Act’s notice-and-comment requirements.
|Awaiting FDA response.|
More Information and Downloads:
4/8/2014: Download the Comments