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Eye Drop Quality Issues: Can the FDA See This One Through?
Lyla R White1, C Michael White1
1School of Pharmacy, University of Connecticut, Storrs, CT, USA.
The Annals of Pharmacotherapy
|February 21, 2024
Summary
The Food and Drug Administration (FDA) lacks resources for proactive inspections, especially for lower-priority over-the-counter (OTC) products. Increased funding is crucial to prevent harm from contaminated drugs and ensure public safety.
Area of Science:
- Public Health
- Regulatory Science
- Pharmaceutical Manufacturing
Background:
- The Food and Drug Administration (FDA) faces resource limitations impacting its inspection capabilities.
- Proactive surveillance of foreign manufacturing sites has decreased, leading to reliance on reactive, for-cause inspections.
- Over-the-counter (OTC) products are identified as a lower priority for FDA oversight.
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