Posted: 29 Feb 2016 01:21 AM PST
By Allyson B. Mullen –
By In early February, Booz Allen Hamilton (“Booz Allen”) issued its Final Implementation Report assessing the actions taken by CDRH to address the firm’s earlier recommendations to improve the Center’s premarket review activities. We previously blogged on Booz Allen’s recommendations and CDRH’s plan of action here and here.
Booz Allen’s report summarizes a number of key projects completed by the Center in an effort to promote predictable, efficient, and consistent premarket reviews. These projects address all 11 of Booz Allen’s recommendations from its earlier reports. A few of the most notable actions taken by CDRH are:
It is also too soon to know if these efforts will translate into shorter or more predictable review times for industry. In the report’s discussion of CDRH’s actions leading to the steps above, there are a few interesting points/statistics:
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