New internal guidelines and response times are helping too. Dr. Eydelman said her office now has specifically charged with expediting information requests. A product developer looking at a first in-human study, for example, can email the FDA and get a quick, complete response on how to proceed, usually in two business days.
“The response will have links to all of the guidances and guidelines and all of the relevant information that will get you to an actual submission,” Dr. Eydelman added. “At that point you can ask product specific questions and come and meet with us. We will be able to provide you with expeditious answers.”
The agency is trying for similar flexibility in drug trials and approvals. FDA is bound by laws to require accurate and well-controlled trials. Everything else is up for discussion.
“We really don’t care what you do in phase I or phase II,” Dr. Chambers said. “We try to give as much leeway as we can to help people obtain enough information to plan their phase III trial. If you do it right, you can start with a phase III trial and get approval.”