March 2014

The Myth of the Generic SOP

Posted on Mar 24th, 2014 by Norm Howe

How many times has this happened to you?  You have been assigned the task of writing a Standard Operational Procedure (SOP).  When you grimace and explain that you don't have an extra eight hours to spend on it, your boss says "Why can't we just download a generic one off the internet?"

He says this with such naivete that you realize that more discussion is pointless.  You decide to give in and go along.  Big mistake.

Dear FDA, The Inconsistency is Killing Us

Posted on Mar 15th, 2014 by Norm Howe

VariabilityHey FDA, you do a necessary job.  And you’re good at it.  Mostly.

But you could do a lot better.

When you inspect us, you require consistency; rightfully.  You tell us that we have to be consistent in our application of our procedures within an individual site, and between sites.

“When I Go Slow, I Go Fast”

Posted on Mar 9th, 2014 by Norm Howe

Japanese carpenters have this saying. 

American carpenters have a similar saying, “Measure twice, cut once.”  What do these two quotes have to do with a blog about regulatory compliance?  Everything!

Off-Label Use of Medical Devices

Posted on Mar 2nd, 2014 by Norm Howe

When a patient comes into a physician's office, the patient is looking for the best, most modern care they can get.  And a physician certainly wants the same thing.   

This search for the best possible treatment presents a dilemma, however.  When might the best treatment also be a treatment that is still in the process of being developed?  When might a physician's search for the most advanced treatment cross over into medical research, and where does FDA draw the line between the two.  The answer is clear in some cases, but not so clear in others.