One of the keys to understanding generic drugs is to consider the legislation. Generic drugs were modernized in 1984 under the Hatch-Waxman Act. This Act created an abbreviated mechanism for generic drug approvals, stating that pre-clinical and clinical testing did not have to be repeated for generics. The legislation helped establish when generic products can go on the market. A generic drug can be marketed after the patent and exclusivity protection has expired, or been waived, and when FDA scientific and regulatory issues are met.
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