FDAnews Drug Daily Bulletin

FDA’s New Inspection Protocol Designed to Improve Consistency, Targeting

Nov. 4, 2016

The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent.

“As a pharma company if you’re going to submit a new drug, instead of a 30 percent chance of getting a pre-approval inspection, it’s now 50/50,” said John Avellanet, managing director & principal of Cerulean Associates. “So now instead of threatening your management and saying we might get an inspection, it’s more like we’re going to get inspected unless they were just here.

“No more are you going to have a situation where a company has submitted a drug for approval and the agency pops by six or nine months later and finds out they can’t even spell the drug, which is something you can see today.”

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