1. Pink Sheet

FDA's Rollout of New Inspection Protocols May Begin Next Year

 
• By Bowman Cox

Despite great enthusiasm within the agency for a New Inspection Protocols Pilot Project, FDA officials are saying they don't expect to adopt the protocols for broader use in pharmaceutical facility preapproval and surveillance inspections until perhaps sometime in 2017. The protocols could make inspections more comparable – and could bring recognition to facilities that go beyond compliance.

FDA's New Inspection Protocols Project is proceeding at a slower pace than agency officials were hoping a year ago, which means FDA won't begin using the protocols on a routine basis until next year at the earliest.

The promise of NIPP: inspections that are more comparable from one site to another and from one investigator to another – and that recognize when facilities exceed basic compliance. (Also...

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