In a statement to the US Senate appropriations committee, Food and Drug Administration Commissioner Scott Gottlieb reiterated his goal of “modernizing generic drug development and review,” with the aim of boosting competition in the sector and increasing rates of generic substitution, ultimately in order to lower drug costs.
Generics reform
Dr Gottlieb said a new process of generic drug application would facilitate submission of new generic drug applications, and their review, through the use of a structured template that reduces the number of review cycles.
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