2005D-0203 Guidance for Industry on Safety Testing of Drug Metabolites
FDA Comment Number : EC7
Submitter : Dr. Soraya Madani Date & Time: 08/05/2005 04:08:59
Organization : Novartis Pharmaceuticals Inc.
Category : Drug Industry
Issue Areas/Comments
Dear Sir/Madam:

The attached comments on the draft guidance are submitted on behalf of Novartis pharmaceuticals. 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 more than 78,000 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.

The publication 'Guidance for Industry: Safety Testing of Drug Metabolites' addresses the need to identify, characterize and evaluate the safety of unique major human metabolites, which may not be adequately assessed during standard nonclinical studies. The guidance further recommends specific studies for assessing the safety of metabolites and their timing in the drug development process. The document emphasizes that the identification and understanding of human metabolism early during drug development is important for the overall safety assessment. We are in agreement with many of these points although some may require further clarification or deserve additional discussion. Please see the attached our comments for your consideration.