FDA CBER: gene therapy: delayed AE

Guidance for Industry: Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse EventsPosted: 11/28/2006

EMEA ICH related document

ICH関連でいくつかEMEAから出ました：
28/11/06 Note for Guidance on establishing definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
http://www.emea.europa.eu/pdfs/human/ich/43798606en.pdf

28/11/06 Updated Questions & Answers - Common Technical Document for the Registration of Pharmaceuticals for Human Use
http://www.emea.europa.eu/pdfs/human/ich/082006en.pdf

27/11/06 ICH Considerations - General principles to address the risk of inadvertent germline integration of gene therapy vectors
http://www.emea.europa.eu/pdfs/human/ich/46999106en.pdf