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BioPharmaceutical United States Regulation

FDA ‘Monster’ Patent Reg: Brands, Generics Each Want More Options To Pick Fights

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Executive Summary

PhRMA is concerned about the agency giving deference to generic sponsors in patent use code disputes, while GPhA wants a mechanism to challenge refuse-to-receive letters.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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