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 Role of a US Agent
What is an Agent, from a Pharmaceutical sense? For the US, an Agent is simply someone designated to interact with the FDA on your behalf....
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...
New Consultants and Partner!
Hello all, and welcome to the Holiday Season! While we have been a bit quiet publicly here at LRCG, behind the scenes, we have been...
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*...
WHO and Zika
According to the World Health Organization (WHO), the Zika virus is no longer an international public health emergency. This will not...
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...
Study information on celecobix
According to a new study published in the New England Journal of Medicine, celecobix (Celebrex) is as safe as, and "may even be safer...
