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Show posts for: Food, Drug, and Cosmetic Act

Senate Tweaks Hatch-Waxman with Bill To Codify FDA’s “Active Moiety” Regulation

April 12, 2021 | Andrew N. Goldfarb
To clarify a long-running, hotly-litigated question regarding when a new drug qualifies for exclusive marketing rights intended to reward innovation, Congress has taken an important step toward amending the Federal Food, Drug, and Cosmetic Act (FDCA).
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- Food, Drug, and Cosmetic Act
- Hatch-Waxman Act

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