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Generic drug products have gained huge market share since the 1984 passage of the Hatch-Waxman Act, which for the first time established a pathway for the approval of generic drugs (excluding the ‘Paper NDA’ pathway). By many estimates, generic competitors control more than 80% of the market once they are introduced, creating a strong incentive for many companies to compete for the market share of popular drugs. But as a recent Warning Letter from the US Food and Drug Administration (FDA) points out, sometimes even the most common of generic drugs are manufactured outside of acceptable standards.
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