Tag: drug approval process
FDA Approves Record Number of Generic Drugs in 2018

With U.S. drug prices among the highest in the world, generics provide significant financial relief for millions using prescription drugs.

Good and Bad News on Generic Drug Approvals

A solution to expensive patented medicines is generic competitors. The United States has struck a pretty good balance between innovation and low prices through the Hatch-Waxman (1984) Act, which specified patent terms for newly invented medicines, and a pathway for generic competitors to enter the market after a period. One obstacle to generic entry...
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