Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Registration Number: EAPE -53

Accepted - Volume 3

Registration for FDA Regulation of Combination Products
Name Mr. David Fox
Organization Hogan & Hartson LLP

1. Brief statement of the general nature of the views you wish to present. I wish to make a presentation on questions 1,2,3,4, and 7 as set forth in the meeting notice. As a former FDA associate chief counsel involved in numerous combinatin product decisions, I wish to discussthe regulatory structure under which combination products have been made in the past, and discuss some ideas for improving the agency's overall approach from a regulatory and procedural perspective. Among other things, I would like to discuss the problem of dual action products (question 2), the issue of whether and when more than one application should be used (questions 3 and 4), and the cross-labeling issue (question 7). My presentation will focus more on drug and biological issues than on medical device issues, more on review issues than on GMPS and QSRs, and more on legal/regulatory than on science.
2. The names and address of all persons who will participate in the presentation. David Fox, Hogan & Hartson LLP, 555 13th Street, NW, Washington, DC 20004
3. Approximate time that you request to make your presentation. 15 minutes
4. Special Accommodations required. Please specify. None, thank you.

EAPE -53