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....
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...
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...
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...
FDA updates Guidance on Race and Ethnicity Data Collection in Clinical Trials
On October 26, 2016, the US Food and Drug Administration issued an update to its Guidance on the collection of Race and Ethnicity Data as...
What is Regulatory Affairs?
In its simplest sense, just what is a Regulatory Department of a Pharmaceutical Company. The truth is that many people outside of...
