The FDA has unveiled plans to speed the availability of generic drugs after first-to-file rights expire, Bloomberg reported Thursday.
FDA Commissioner Scott Gottlieb explained that the initiative seeks to clear the backlog of applications awaiting review and approval.
"Soon after the 180-day exclusivity period lapses, consumers can have the benefit of brisk competition from multiple other generic entrants," Gottlieb stated, adding "this can improve affordability and access to important drugs."
Gottlieb previously promised to clear the backlog of generic drug applications within a year.
Gottlieb also indicated that the agency will prioritise applications seeking approval of therapies with less than three generic options.
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