Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs

Volume: 11, Issue: 12, Pages: 1637 - 1647
Published: Dec 1, 2010
Abstract
The 2010 US FDA–Drug Industry Association (DIA) Pharmacogenomics (PGx) Workshop follows a series that began in 2002 bringing together multidisciplinary experts spanning regulatory authorities, medical research, healthcare and industry. This report summarizes the ‘Building PGx into Labels’ sessions from the workshop, which discussed the critical elements in developing PGx outcomes leading to product labels that inform efficacy and/or safety....
Paper Details
Title
Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs
Published Date
Dec 1, 2010
Volume
11
Issue
12
Pages
1637 - 1647
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