Are there areas where regulatory agencies are expecting too much data?
Our experience with the various regulatory bodies has been good. Yes, there’s a lot of information that is required. We were the first ones to really go in front of FDA with an amplification-based technology. That posed challenges for both FDA and for us. So we did have to provide a lot of information on all the various aspects of the kit performance and our manufacturing processes, which I don’t think is any different from what is provided for an immunochemistry test. I think the challenge also comes in determining the clinical utility of these kits. In the United States, a test doesn’t get approved simply because it detects the number of copies of RNA that it claims to detect. A manufacturer has to prove that there’s a clinical use for the test. That is probably the biggest challenge because those types of studies generally take a longer period of time to conduct. What areas of the IVD Directive, which will become effective in December 2003, have you found most difficult to deal with
Related Questions
- In the Appendix C Demographics Chart, if agencies do not capture data on certain areas of the volunteers, staff, board, and clients, how do they reflect that?
- Can we use data from samples split with regulatory agencies on our DMR? Why would one choose to split a sample?
- If I hire Cashins & Associates, is my data going to be reported to OSHA or State Regulatory Agencies?
