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...
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*...
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...
Orphan Indications
"The three most important things for companies tackling rare diseases to get right are regulatory affairs, regulatory affairs, and...
EMA Webinar for Type 1 Variations
Copied from the EMA Website: The European Medicines Agency (EMA) is organising a webinar on 15 November 2016 to advise stakeholders on...
Pay-to-delay decision
This Tuesday it was announced that the US Supreme Court had declined to hear an appeal from the US Appeals Court which focused on the...
eCTD Mandate at FDA
So what do you need to know for the upcoming mandate from the FDA to switch submissions to electronic? How long do you have to make the...
