FDA to cut inspection-to-warning time

As most business travelers will agree, trip reports become much harder to complete once the traveler gets back to the office. So too with warning letters for regulatory inspectors when they return from the subject facility. 

But work is underway to change that, following a mandate from FDA commissioner Margaret Hamburg. "The commissioner said the timelines [between inspection and warning letter] are too long. We were told to improve the system," says Rick Friedman, FDA director at the division of manufacturing and product quality, during a regulatory town hall meeting held this week at the ISPE annual meeting in San Diego. FiercePharma Manufacturing finds in a recent report, "Top 12 GMP Violations," an average of nearly seven months between inspection and warning letter, with the shortest at five months and the longest at 13 months.

Friedman says the FDA is working to improve those times by streamlining management review of the warnings and looking for ways to help busy inspectors complete the task more expeditiously. Perhaps a target of no more than six months? "I think we can do better than that," he says.

- find FDA warning letters here

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.