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FDA Must Act To Improve First-Review Cycle Approval Rates

 
• By Aidan Fry
  
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Greater clarity in reviewers’ comments and limiting the effect of originators’ label changes on pending applications would help improve the rate of generic applications approved by the FDA on the first review cycle, a US government report proposes.

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First-cycle review approvals of generics in the US must be approved, a government report suggests • Source: Shutterstock

Additional steps must be taken by the US Food and Drug Administration to increase the rate of generics approved after their first review cycle, according to a report to congressional committees made by the US Government Accountability Office. Between 2015 and 2017, the GAO report observes, just 12% of generic applications were approved on the first cycle, with dossiers on average going through three review cycles before being signed off by the FDA, a process that can take several years.

In its report, the GAO acknowledges that the agency has made efforts to get more generics approved on the first...

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