Episode 3: Beyond Borders: Comparing How Global Agencies Regulate Chiral Drugs
“Science may be universal, but regulation wears many faces. Let’s journey through the world of chiral drug approval across continents.” Introduction The 1990s witnessed a revolutionary shift in the regulatory treatment of chiral drugs, spurred by major agencies like the U.S. FDA and European Medicines Agency (EMA). However, the global regulatory landscape was -and still is -far from homogeneous. While scientific consensus around the importance of stereochemistry has largely been achieved, regulatory expectations, procedural details, …
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