Today we want to focus on key lessons learned from our clients’ experiences. We are very grateful to these clients for allowing us to share their experiences with you so that you can do a better job in your REMS process.
Let’s begin with something that happened recently as we were working with a client during the tight 90-day period before they presented their PDUFA.
Expect the Unexpected
As we work with our clients on their REMS process, we are learning a lot about the uncertainties of interfacing with an internal FDA process that is itself a work in process. One thing that has become very apparent is that no matter how much advanced preparation you believe you have done, the FDA might just surprise you. (more…)
