Webthe Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER ... WebSep 28, 2016 · The Hatch-Waxman Act established an expedited pathway for generic drug companies to obtain Food and Drug Administration (FDA) approval for their products. It also created a statutory “safe harbor” that shields generic applicants from charges of patent infringement until such time as they request approval to market their products from the FDA.
What is Hatch-Waxman? PhRMA - Pharmaceutical …
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The Hatch Act: A Primer - Federation of American Scientists
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