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Rulemaking Process Flawed, But Making Monograph Rules Still Needs Funding

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.

The federal rulemaking process, FDA officials say, is not an ideal framework for staying on top of OTC drug innovations and emerging safety questions. It is the agency's only choice, though, and additional resources are needed to facilitate rulemakings in its monograph drug program.

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