FDAMA Pediatric Exclusivity Expansion Could Be Considered By FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA may be willing to discuss new incentives for manufacturers to conduct pediatric studies on products not covered under the FDA Modernization Act's pediatric exclusivity rule, FDA Commissioner Jane Henney, MD, said at a Senate Health, Education, Labor & Pensions Committee hearing on FDAMA Oct. 21.
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