New FDA Protocols Will Soon Boost Inspection Consistency

 
• By Bowman Cox

By the end of next year, new FDA protocols could bring more consistency from one inspection to the next and from one investigator to another.

FDA is piloting a new and very different way of inspecting pharmaceutical manufacturing facilities that has drawn rave reviews from investigators who’ve tried it, and that in little over a year could begin bringing benefits to drug makers, particularly those running high quality operations.

Possibly by the end of 2016, the agency expects to be using its new inspection protocols for all preapproval and...

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