Safety Reporting: What It Is and Why Is It Important
One of the more important aspects of working in pharmaceuticals is ensuring the products are safe for human use. This means the proper...
The Briefing Book
The Briefing Book is, in my opinion, one of the most critical documents in Regulatory Affairs. This is your opportunity to tell your...
The future of Drug Development in the US
(Image: By Zach Rudisin - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=20727816) Currently, in the United...
Thoughts on FDA AdComms
Generally I don't like vague posts, but this one needs to be a little vague on purpose. This may be the lawyer in me, but when you are...
The Role of Regulatory in Safety
This is one of those that generally varies from company to company, but one thing that is important to remember is that Regulatory *does*...
Opioids - Where are we now?
Back in 2009, the FDA began meeting with companies regarding Long-Acting/Extended Release Opioids. The purpose of these meetings was to...
PDUFA VI - Some thoughts
At the end of 2017, PDUFA V expires, so the FDA is currently looking at options in PDUFA VI. It will be vital to understand these...
Orphan Indications
"The three most important things for companies tackling rare diseases to get right are regulatory affairs, regulatory affairs, and...
Thoughts on the FDA
This past Veterans Day, the US Food and Drug Administration posted a blog on the race to get penicillin to soldiers in WWI. This made me...
FDA Inspections - How not to do it
Looking through the FDA's website, the section on Warning Letters is always worthy of a brief read. This is where you can find out which...
