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Pharmaceutical Industry Food and Drug Administration (FDA) Exclusive Dealing Agreements

Morgan Lewis

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

Morgan Lewis on

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

Wilson Sonsini Goodrich & Rosati

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

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