by Robert Seevers | Mar 8, 2019
If you visit a doctor and receive a diagnosis stating that you require major surgery, would you just accept that and get on with the procedure? Or, would you seek a second opinion before going under the knife? Second opinions can be just as important in the regulatory...
by Robert Seevers | Nov 26, 2018
Many people working in drug development have expressed the frustrated wish that regulators would just go ahead and tell them exactly what they must do in order to move their drug through the development and approval process. The level of exasperation with the...
by Robert Seevers | Oct 19, 2018
“I guess the question I’m asked the most often is: “When you were sitting in that capsule listening to the count-down, how did you feel?” Well, the answer to that one is easy. I felt exactly how you would feel if you were getting ready to launch and...
by Robert Seevers | Sep 21, 2018
Metadata is data about data. That may sound confusing, but it will come clear in a moment, I promise. The background for this is the fact that FDA now requires electronic rather than paper submissions. The idea here is that electronic submissions will be easier to...
by Robert Seevers | Jul 17, 2018
As of May 5, 2018, all submissions to FDA must go through the Agency’s electronic gateway. There are three parts to processing electronic submissions with FDA. They are: Transforming the documents into pdf format. Placing the individual PDFs into the electronic common...
