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...
