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As proposed at 428.101(a)(3)(iii), to determine whether the manufacturer of the generic drug is a first applicant during the 180-day exclusivity period, or whether the manufacturer of the generic drug is a first approved applicant for a competitive generic drug therapy, CMS would refer to FDA website resources such as the Orange Book and may consult with FDA for technical assistance as needed

If the book contains insights that inform the reading audience, then the advancement of scholarship achieved by this book is predicated upon the volumes of excellent work that precede it

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doi: 10.1053/j.gastro.2019.08.042 208 DerlerIJardinIStathopulosPBMuikMFahrnerMZayatsVet al