Thalidomide --The Drug and Woman That Changed the FDA Forever
Inside Out Quality
English - February 09, 2021 11:00 - 1 hour - 44.5 MB - ★★★★★ - 6 ratingsScience quality assurance sdbio biotech medical devices Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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In the late 1950's a new drug was launched in Europe. Clinical trials weren't like they are today; as a result, thousands of children suffered from extreme birth defects or died before birth due to Thalidomide. Frances Kelsey, a new FDA reviewer, pushed for safety data before allowing it to be approved US, and spared the US from tragedy.
We are joined by Neil Vargesson, Chair in Developmental Biology and expert in Thalidomide, as we discuss the drug's history and how it caused birth defects. Justine Peterson, P.A., joins us also to give a clinical perspective on drugs, trials, and how they shape her world.