FDA should move the OTC drug review out of the Office of New Drugs to increase the program’s decision-making authority and accelerate completion of OTC monographs, suggest two food and drug attorneys who led the launch of the program in the 1970s.
New Home For OTC Drug Review Would Restore Momentum – Hutt, Yingling
“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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