Regulatory Focus™ > News Articles > Perspective: Generic Drug approvals in the US Prior to the Hatch-Waxman Act

Posted 01 September 2008

Perspective: Generic Drug approvals in the US Prior to the Hatch-Waxman Act

It is a common misconception that the Hatch-Waxman Act of 19841 created the generic drug approval process in the US. A recent article claimed there were few generic drugs approved in the US before that act was passed.2

 

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