Hi RegEx Members, As our RegEx year in review week comes to an end, we thought it would be fitting to close out with some things to look forward to in the coming weeks and months. RAPS will be launching a brand-new community on RegEx for our Executive Development Program in conjunction with Northwestern Kellogg School of Management very soon. ...

​Hello Peter, To be honest, I was hoping to see some replies to this question to see what others suggest or have done themselves. Hopefully, there were private replies to help you out. My thoughts…The problem is not just that the Declaration of Conformity is misleading, but your product is also mislabeled with the CE Mark. You do need to contact the ...

For User fee products (drugs, devices, biologics, generics) the money to cover the cost of the inspection now comes out of the user fee that is paid.  Since the money is paid to cover review activities, this includes inspections related to the review. Routine GMP inspections are also covered by the annual product fee that is paid for each approved ...

Not sure whether it is becoming a standard request, but I have been requested to submit a MBR for a biotech product in the past. I still would not submit it unless requested. ------------------------------ Glen Park Jersey City NJ United States ------------------------------

Perhaps I did not make clear that I agree that it would be difficult to obtain approval for an original NDA/BLA solely on the basis of Real World Evidence. As I stated at the outset, I am using the definition of Real World Evidence as information obtained using research methods other than a randomized, controlled clinical trial. Demonstration of penicillin ...