(Joint Meeting with Bio-products Subcommittee)
Date and Time: September 27, 2013 from 4pm to 6pm
Agenda / List of Handouts
Agenda
Clinical Evaluation and Biomarkers
(1) Companion diagnostics
(2) Others
List of Handouts
Document 1 Drafted guidance on companion diagnostics
Ref.1 Direction and method of discussion at the joint meetings of the Pharmaceuticals and the Bio-products Subcommittees (draft)(The same material as the material #1 of the 4th Pharmaceuticals and Bio-products joint Subcommittee meeting)