| 2006N-0107 | FDA-Regulated Products Containing Nanotechnology Materials | |||||||||||||||||||||||
| FDA Comment Number : | EC4 | |||||||||||||||||||||||
| Submitter : | Dr. OLUWOLE ODUJINRIN MD | Date & Time: | 06/05/2006 07:06:49 | |||||||||||||||||||||
| Organization : | Customized Therapeutics | |||||||||||||||||||||||
| Category : | Drug Industry | |||||||||||||||||||||||
| Issue Areas/Comments | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| We very much would like to participate in the proposed conference and workshop. Our company is working on some nanomedicine products for which we have developmental and regulatory issues that are beginning to challenge us due to absence of clarity in this area.
Not only are we interested in participating, I personally would like to volunteer to be involved in the planning group for the proposed workshop. I was an FDA Reviewer in the Oncology Products division (DODP) of CDER from 1997 to 2000. I am also currently a practicing Medical Oncologist as well as the Chief Medical Officer of an emerging bio-pharmaceutical company. I believe I make very useful contribution to the planning and execution of the conference/workshop. THANKS O. ODUJINRIN MD | ||||||||||||||||||||||||