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Federal Preemption and OTC Drug Efficacy: Lessons from the Phenylephrine MDL

New decision from the District Court for the Eastern District of New York finds that the FDA has exclusive authority to determine whether OTC drugs are effective. Court found that manufacturers of OTC drugs do not have an...more

FDA Issues Final Rule Clarifying Evidence of Off-Label Marketing

Key Takeaways - Following more than five years of revisions and delays, the U.S. Food and Drug Administration (“FDA”) published its final “intended use” rule (the “Final Rule”) and amended its regulations describing the types...more

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