Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Registration Number: EAPE -47

Accepted - Volume 3

Registration for FDA Regulation of Combination Products
Name Dr. Guy Chamberland
Organization Angiogene Inc

1. Brief statement of the general nature of the views you wish to present. This presentation would be combined with the previous topic registered regarding Orphan Designation. The additional views that would be presented include: 1) Premarket review mechanism for regulating combination products: the review mechanism should ensure that safety and efficacy issues related to each component of the combination product be adequately addressed and that regulatory benefits provided by each premarket regulatory process (NDA, BLA or PMA) be retained for combination products. 2) A mixed regulatory approach should be applied to both premarket applications (PMA, BLA, NDA)and drug/device Good Manufacturing Practices (QSR, GMP). A mixed approach is required to ensure safety and efficacy of each component.
2. The names and address of all persons who will participate in the presentation. Guy Chamberland, Ph.D. Angiogene Inc 1851 Sherbrooke east Suite 704 Montreal, Quebec, Canada H2K 4L5
3. Approximate time that you request to make your presentation. total for both presentations registered: 20 minutes
4. Special Accommodations required. Please specify. PowerPoint presentation

EAPE -47