GDUFA, Take II

GDUFA’s second iteration emerges from backlogs and negotiations, promising speed, clarity and transparency

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Just over a decade ago, the generics industry began enjoying remarkable success, growing rapidly and globalizing its manufacturing. This success, however, brought with it a significant regulatory challenge, and delays in generic drug approvals emerged as a major concern for the generics industry, FDA, consumers and payers, as the agency fell further and further behind in review and inspection capacities. Signed into law in 2012, the Generic Drug User Fee Act (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the FDA’s costs of reviewing generic drug…

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