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Rulemaking Process Flawed, But Making Monograph Rules Still Needs Funding

This article was originally published in The Tan Sheet

Executive Summary

The monograph program was "instituted really many, many decades ago. We've been trying to implement it since," says CDER Director Janet Woodcock. "We haven't had a much bigger pie to play with, so that's been one constraint that we've had to deal with," says center budget chief Donal Parks.

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