“it has been good working with the majority. We cannot agree on this amendment. Even the FDA has asked for this amendment. When they testified before our committee in January, they said the weakness is labeling. "The goal of pediatric exclusivity should be labeling," that is a quote from the FDA. Section 552 does not work in the real world; that is why we need this amendment.”
Discussing the need for an amendment related to pediatric exclusivity and FDA labeling during a committee meeting.
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