Tag: Hatch-Waxman Act
FDA Safety Standards: How Generic Drugs Meet Brand Name Requirements
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Written by Clarissa Farnell
12/ 06
Explore how FDA safety standards ensure generic drugs meet brand name requirements through bioequivalence testing, cGMP manufacturing, and the Hatch-Waxman Act framework.
Federal Circuit Court: Authority on Pharmaceutical Patent Cases
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Written by Clarissa Farnell
26/ 01
The Federal Circuit Court controls U.S. pharmaceutical patent law, shaping how generics enter the market, how patents are challenged, and whether new dosing regimens can be protected. Its rulings impact drug prices, innovation, and billions in revenue.