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FDA Eyes Manufacturers of Eye Drops

The agency wants mandatory recall authority for drugs and increased funding for foreign inspections to address challenges.

Tima Miroshnichenko
Tima Miroshnichenko

You may have noticed the uptick in eye drop recall headlines this year. According to a recent BOSTON.com article, the FDA is now seeking new powers from Congress, including the ability to mandate drug recalls and enforce inspections of eye drop manufacturers before products are shipped to the U.S. Experts emphasize the need for increased staff and resources for foreign inspections, which have been challenging even before the COVID-19 pandemic, with a 79% decrease in FDA foreign inspections in 2022 compared to 2019. The FDA is also seeking the authority to require eye drop manufacturers to provide at least six months' notice before shipping products from a new factory to allow for inspections.

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