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This document summarizes the Hatch-Waxman Act, which was introduced in 1984 to balance pharmaceutical innovation and generic drug competition. It established an Abbreviated New Drug Application process allowing generic drugs to gain approval by relying on safety data from brand name drugs. This streamlined the approval process for generics. The Act also provides incentives for drug innovation through patent term extensions and periods of market exclusivity for brand name drugs. Its overall goals were to inc

Author

Anil kumar

Language

EN