The U.S. Food and Drug Administration recently released two new draft guidances designed to provide drug manufacturers with increased information and recommendations for conducting clinical lactation and pregnancy studies. While these guiding docs are still in draft form, they’re a step in the right direction when it comes to keeping pregnant and breastfeeding women safe.

Studying the effectiveness of medications in lactating and pregnant women isn’t exactly easy. This makes finding or getting high-quality data almost impossible for researchers and manufacturers.

photo: Victor Pinto via Unsplash

There are obvious ethical issues at play when it comes to testing the effectiveness of medications on pregnant and breastfeeding women. Beyond harm to the women, there’s also the potential to harm the fetus or infant. The FDA’s new draft guidance for clinical lactation studies expands upon previous statements, provides recommendations for when companies should conduct studies and when lactating women can participate in trials.

The second draft helps to guide manufacturers and researchers in using data (such as real-world date) in studies focusing on pregnant women and FDA-regulated drugs/biological products.

So what does this all mean for you? Right now, not a lot. But in the future it could help drug manufacturers to study the effectiveness and dangers of medications, reducing the risk to pregnant and breastfeeding mamas.

—Erica Loop



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