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Whitney Hapangama

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Changes in US Policy: What Generic Pharmaceutical Companies Need to Know

Changes in US Policy: What Generic Pharmaceutical Companies Need to Know

Deborah Yellin;Whitney Hapangama
February 1st 2004

In this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2

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