Improvements in FDA Approval Timelines

According to a third party report by Pricewaterhouse Coopers (PwC), the Food and Drug Administration (FDA) has decreased the standard review time for new drugs, biologics, and devices. The report indicates the standard review time in 2009 was 14 months, but in 2012, it had decreased to 7 months.

Although low-priority new drug applications continue to require multiple review periods, high-priority applications were approved in the first review process at a rate of 81% in 2012. That represents a substantial increase in approval rates during the first review process. Similarly, as part of the Food and Drug Administration Safety and Innovation Act of 2012, the breakthrough therapy pathway has proven successful. Since its inception, it has received 260 applications, designating 74, and approving 17.

A full copy of the report regarding the FDA can be obtained at the following link:

© 2015 Houghton Vandenack Williams

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