OTC Monograph Process In “Slow Death Spiral” From FDA Neglect – Hutt
This article was originally published in The Rose Sheet
“By your actions you have shown you don’t want the review to be completed,” former FDA chief counsel Peter Barton Hutt tells agency officials at a public hearing. Hutt and former agency attorney Gary Yingling suggest FDA move the OTC drug review out of CDER’s Office of New Drugs.
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