1	IVD Round Table Issues and Discussion Leif Olsen and Susan Tiedy-Stevenson RA Specialists Hogan & Hartson L.L.P. September 14, 2006
2	User Fees Performance Goals AdvaMed is negotiating with the appropriate people at FDA on metrics and fees. Comment: The program is not meeting its intent because there are not enough trained reviewers to provide prompt and complete service.
3	OIVD Review Consistency Data requirements appear to lack consistency between Branches. Molecular tests especially seem to have higher data standards.
4	Overall OIVD/CDRH and FDA Organization To increase the number of reviewers – consider elimination of non-core functions and reallocate resources. http://www.fda.gov/cdrh/organiz.html http://www.fda.gov/oc/orgcharts/CBER1.pdf http://www.fda.gov/oc/orgcharts/oc.pdf What would “business” do?
5	Informed Consent Guidance Update This is a major accomplishment of the IVD roundtable and FDA/Industry cooperation clearly allowing banked samples for clinical research. FDA still seems reluctant to accept only banked samples Field inspectors have checklist re. informed consent
6	Guidance Documents and Good Guidance Practice Process GGP transparency is lacking. OIVD should produce a list of guidance documents under development, how they were prioritized, why, and the timelines. This should be, in part, industry driven. The GGP process needs to be updated to allow industry to work with FDA on these projects. Specific issue: Industry was pressed on an update of the ASR Q & A. Submitted it to OIVD in December 2005 and it still hasn’t appeared.
7	Home Brew, ASR – Lab Developed Tests Still a major topic – the playing field is still not anywhere near level. How will this field evolve?
8	Migration Studies IVD Industry would like to see a formal guidance. When FDA proposed the migration study in July 2004, CBER indicated that they were doing this to be consistent with CDRH. However, CDRH does not appear to apply or rely on migration studies consistently. The data requirements appear murky and variable. Where are we going with this concept?
9	Addressing Additional Data Requests How does industry manage submissions if there is informal agreement with a study prior to submission, and reviewers decide they want a different study or additional data after the submission has been filed? When data are very good and you get a CRL or NSE asking for more data anyway, how do you proceed? Are data requests communicated in a timely fashion? How do we further improve communication between the Centers and industry?
10	MDRs This is a process that hasn’t worked well from the beginning. Time to revamp?
11	Genetic tests – Including Home Sample Collection What’s the future for laboratory developed test and will home collection interference stop the trend?
12	Meetings with CBER/CDRH – Different SOPs Many differences between how each Center interacts with industry CBER is very formal and adheres strictly to meeting timelines per "Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products" (Feb 2000). CDRH encourages informal meetings because it makes the early (informal, Determination and Agreement) meetings more productive.
13	Meetings CBER/CDRH – Different SOPs (continued) This difference is very apparent and causes industry to tailor its procedures differently and timeline projections poorly. It is also difficult to explain to company staff and management why the communication approach of each center is different. Each center’s approach to meetings with industry carries over into how reviewers interact with the company during review of an application: CDRH staff calls frequently CBER staff discourages any interactions with reviewers and requires all communications to channel through the project manager.
14	Meetings CBER/CDRH – Different SOPs (continued) This has a direct impact on efficiencies, review times and a sense of collaboration (i.e., the feeling is that CBER is not working with industry as well as CDRH). The industry needs a higher level of support at the Center to have CBER follow the interactive CDRH system. Individual CBER instances of interactive reviews do not represent overall policy or practice.
15	Time to Market Best efforts to develop and define a clinical plan with CBER and CDRH prior to submission can still result in a delay to market, even with submissions based on that information. After a company submits the data agreed to/requested by FDA at pre-IND, pre-BLA or pre-IDE meetings, often reviewers still want more testing or additional requirements to be met.
16	Time to Market (continued) The purpose of these planning meetings is to get agreement so that industry can facilitate the review by FDA and ensure an efficient, predicable time to market for its products. How can industry ensure that the pre-submission meetings will consistently result in quicker reviews by FDA?