I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office a little bit confused, and then it dawned on me that she did not want me to cause any sort of mass destruction...just to look at the BOM (Bill of Materials). Phew! It's just part of the jargon of the industry. Everyone uses abbreviations, numbers, code names, and pneumonic devices to mean any number of very important things.

You may go home and talk to your husband or wife about that 510(k) you just submitted at work. They may be wondering what new type of retirement plan your company is offering. What's the difference between the 401K plan and the 510(k) one? A higher rate of return? What a deal! But in reality, 510(k) is really just a reference to a section of the Food Drug and Cosmetic Act for premarket notification.

Another one I've seen get confused is NDA. An NDA is a New Drug Application, which is the route that drug sponsors must go through to market a new pharmaceutical. I was reading an article recently about Delcath Systems a really neat company in New York who is developing a combination product to treat cancer. The article was applauding the company for their regulatory progress, and its successful filing of a non-disclosure agreement with the FDA. Now, while I do think confidentiality is an important part of the regulatory process, I'm pretty sure that this article got their NDA acronyms backwards.

It's hard to keep the acronyms and names and numbers straight sometimes, but we all enjoy a little chuckle whenever they end up having double meanings. I think I'll stick to the BOM business, instead of the bomb one.


Share your funny stories about terms that you use!

- Sherri

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!