2004D-0117 - International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
FDA Comment Number : EC3
Submitter : Dr. Judith Sills Date & Time: 05/21/2004 04:05:09
Organization : Novartis Pharmaceuticals Corp.
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
May 19, 2004



Division of Dockets Management (HFD-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Comments on International Conference on Harmonisation;
Draft Guidance on E2E Pharmacovigilance Planning
Published on 30 March 2004
Docket No. 2004D-0117


Dear Sir/Madam:

Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in pharmaceuticals and consumer health. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,200 people and operate in over 140 countries around the world.

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis.

As one of the world?s largest pharmaceutical manufacturers, Novartis has committed extensive resources to the handling of safety information for its investigational and marketed products. The proposals outlined in the ICH E2E draft guideline will significantly impact our global safety handling operations and we appreciate the opportunity to offer comments on this guideline.