OTC Hangover Remedy Safety On Tap For FDA Advisory Committees
This article was originally published in The Pink Sheet
Executive Summary
CDER schedules an NDAC and DSRMAC joint meeting while also negotiating with industry stakeholders on a potential proposal for a user fee program to support FDA’s work on finalizing monographs or amending monographs with additional ingredients or indications.
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CDER officials and industry met in July to discuss "the ground rules governing the OTC monograph user fee." CHPA CEO Scott Melville cautions: "No one is going to rush into an agreement that we're going to have to live with for decades."
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.
OTC Monograph 'Disruption' Could Ride On PDUFA Reauthorization's Back
Changing the monograph process would be "one example of where disruption can be positive," CEO Scott Melville says at CHPA's executive conference. Legislation that would be added to the PDUFA reauthorization could be the best chance for monograph reform, but will be a lengthy process.