FDA-Approved Labeling: Is Enough Enough?
FDA Law Blog
AUGUST 21, 2023
Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” But we digress.
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