2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC18
Submitter : Dr. Jeffrey Lerner Date & Time: 08/02/2004 06:08:01
Organization : ECRI
Other Organization
Category :
Issue Areas/Comments
Comment Issues
1. Hurdle Identification. Please describe the product development issue, the nature of the evaluation tool that is out-of-date or absent, how this problem hinders product development, and how a solution would improve the product development process.
See general comment in last field.
ECRI is planning to provide detailed comments shortly. We believe this is an important initiative. Our comments will support continuing and enhanced scientific evaluation of products as a key to improved process.