| Drug Price Competition And Patent Term Restoration Act |
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| 1984 in law | |
| united states federal intellectual property legislation | |
| united states federal healthcare legislation | |
| united states patent law | |
| biotechnology law | |
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Hatch-Waxman amended the Food Drug And Cosmetic Act . Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can filled Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. Section 505(j)(5)(B)(iv), the so called Paragraph IV, allows 180 day exclusivity to people who file suit against holders of Patent s related to branded drugs. |
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