Document details
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/08/WC500170682.pdf
| Download document | Concept paper on good genomics biomarker practices |
|---|---|
| Reference number | EMA/CHMP/PGWP/415990/2014 |
| Status | draft: consultation open |
| First published | 04/08/2014 |
| Last updated | 04/08/2014 |
| Consultation start date | 04/08/2014 |
| Consultation end date | 04/11/2014 |
| Email address for submissions | pgwpsecretariat@ema.europa.eu |
Summary
Genomic data have become important to evaluate efficacy and safety of a drug for regulatory approval. As a result, genomic information has been increasingly included in drug labels relevant for the benefit/risk evaluation of a drug and consequently as guidance for patient treatment.
DRUG REGULATORY AFFAIRS INTERNATIONAL 