Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Registration Number: EAPE -33

Accepted - Volume 2

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. The development of a drug-device combination product involves meeting the regulatory and scientific requirements for both a device and a drug. Drugs are entitled to an Orphan Designation and the Orphan status provides many benefits that encourages companies to develop products for rare diseases. Drugs will bring new therapeutic advantages to devices and Orphan benefits will further encourage development. We believe that the drug component of a drug-device combination product should be entitled to Orphan Designations even when the primary review responsibility is with CDRH (since the combination product has the primary intended purpose of fulfilling a device function) and the combination product is subject to premarket application submission requirements.
2. The names and address of all persons who will participate in the presentation. Guy Chamberland, Ph.D. Vice-President Regulatory Affairs & Drug Development Angiogene Inc 1851 Sherbrooke east Suite 704 Montreal, Quebec Canada H2K 4L5
3. Approximate time that you request to make your presentation. 15 minutes.

EAPE -33