Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Comment Number: EC -11

Accepted - Volume 4

Comment Record
Commentor Ms. Jenny Peters Date/Time 2003-01-21 16:22:49
Organization Pharmacia
Category Company

Comments for FDA General
1. General Comments Dear Sir/Madam, Pharmacia appreciates the opportunity to comment upon FDA regulations. As the Agency works to streamline the processing of complex drug-device, drug-biologic, and device-biologic combination products, Pharmacia would suggest that FDA clarify and harmonize the associated adverse event reporting systems. We thank you for the opportunity to comment. Please let us know if you have any questions regarding this comment. Jenny Peters/Pharmacia/269-833-8141

EC -11