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2. 2004 update--180-day exclusivity under the Hatch-Waxman amendments to the federal Food, Drug, and Cosmetic Act. Lietzan EK. Food Drug Law J; 2004; 59(4):459-63. PubMed ID: 15875350 [Abstract] [Full Text] [Related]
4. Potential pathways for abbreviated approval of generic biologics under existing law and proposed reforms to the law. Dinh TQ. Food Drug Law J; 2007; 62(1):77-137. PubMed ID: 17444027 [No Abstract] [Full Text] [Related]
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