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“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock

 
• By Malcolm Spicer

Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.

FDA is not capable of completing additional OTC monographs without streamlining the process and boosting the Center for Drug Evaluation and Research’s capacity to develop and publish rules, says center Director Janet Woodcock.

Woodcock spoke at the March 25 opening of a two-day public hearing on potential improvements to the monograph system

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