August 13, 2008
Health Canada is pleased to announce the adoption of the ICH guidance entitled, “Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (E15)”.

August 13, 2008
The Guidance Document entitled, “Submission of Pharmacogenomic Information”, has been revised.

August 13, 2008
Stakeholder input is requested for the Progressive Licensing Discussion Paper entitled, “Prescription Drugs Labelled for Use in Pregnancy: Post-marketing Surveillance Strategies - Pregnancy Outcome Data”.

August 13, 2008
Stakeholder input is requested for the Progressive Licencing Discussion Paper entitled, “Prescription Drugs Labelled for Use in Pregnancy: The Need for a Canadian Regulatory Framework”.

July 29, 2008
A Notice of Decision has been issued for the drug product, Zeftera.

July 24, 2008
A Notice of Decision has been issued for the medical device, Procleix Ultrio Assay (Donor Screening).