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Eye Drop Quality Issues: Can the FDA See This One Through?

Lyla R WhiteC Michael White
Published in: The Annals of pharmacotherapy (2024)
The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections.
Keyphrases
  • drug administration
  • public health
  • big data
  • clinical practice
  • current status
  • machine learning