FDA Review Times Steadily Decreasing, Report Finds

Posted 29 March 2016 By Zachary Brennan

Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group.

Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two years for an FDA review has fallen from more than 25% of applicants in 2000 to none by 2013.


However, FDA’s consistency in decreasing the average approval times has not quite translated into decreases in approval times for endocrine, gastrointestinal, genitourinary and central nervous system therapies.

Ten endocrine treatments were approved between 2008 and 2015, though none were approved via an expedited approval pathway, and on average it took about 11 months longer to approve the drugs than others.


In contrast, over the last nearly 15 years, the fastest reviews have been for oncology,infectious and rare disease treatments. More than half of oncology (58%) and anti-invective drugs (76%) were approved between 2008 and 2015 on an expedited basis.


As far as the breakthrough therapy designations, which often cut the drug development timeline of oncology treatments by two years, FDA has expanded the number of therapeutic areas in which it’s granting such designations.


“The FDA has worked diligently to improve overall drug review times and processes — a success to be applauded. As Congress, the agency and the biopharmaceutical industry look toward the next user fee round, we have a great opportunity to replicate those improvements across all therapeutic areas,” the report’s authors concluded.

The report echoes a similar one issued by the consulting group PricewaterhouseCoopers last year, which also found FDA is making sustained improvements to its medical device approval processes.

2016 CLSA Report


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Categories: Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA

Tags: FDA review times, FDA approval trends, breakthrough designations

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