Senate Puts FDA On Notice To Solve FDAAA Sec. 912 Puzzle
This article was originally published in The Tan Sheet
Executive Summary
Senate appropriators say FDA must decide how it will implement a provision of the FDA Amendments Act of 2007 that could substantially stifle innovation in the dietary supplement industry
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FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications
FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912
FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications