Hatch, Harkin Call For Withdrawal of NDI Draft Guidance
By
Carolyn B. Phenicie / Email the Author / “The Tan Sheet” Jan. 9, 2012, Vol. 20, No. 02
On The Hill / Word Count: 441 / Article # 05120109013
Executive Summary
Sens. Hatch and Harkin ask FDA to craft a new document to replace the current NDI notification draft guidance, recommending the agency “provide needed clarification” on what constitutes an NDI.
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