FDA Cycle Times and Compliance

Mark Schwarz reviews FDA compliance times in “Does FDA Need Statutorily Imposed Incentives for Regulatory Compliance Matters?” at FDA Law Blog (a must read blog for those in pharmaceutical, medical device or food quality). I found these cycle-times fascinating.

It also amazes me that after the last few years of the agency pushing quality metrics, this is the first time these numbers have been shared. I deeply hope they drive improvements.

Given these lead times I find it interesting that the FDA has taken to pointing out the need for a consultant in warning letters. By the time a warning letter is obtained, a meeting perhaps held, and a consultant obtained it is easily a year before real work is happening. This does not provide the most nimble of approaches.

Again, a good article I strongly recommend.

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