The Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, is a legal framework authorized by the Congress in 1984.
The Act came into force to streamline the approval process of generic drugs and preserve innovation incentives and establish a procedure for litigation involving generic pharmaceuticals. The Hatch-Waxman Act established a legal as well as the economic foundation for the US generic drug industry.
The Act offers drug developers some protection while facilitating and giving incentives for companies to file an Abbreviated New Drug Application (ANDA).
#drug #hatchwaxmanact #pharmaceuticals #kalkinemedia
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