Press Release
(Joint Meeting with the Pharmaceuticals Subcommittee)
Date and Time: January 30, 2013 from 5pm to 7pm
Agenda / List of Handouts
Agenda
- Personalized medicine
- (1) Current situation explained by the Subcommittee members
- (2) Regulatory trend of personalized medicine
- Ways to proceed future discussions of Pharmaceuticals Subcommittee and Bio-products Subcommittee
- Others
List of Handouts
- Document 1 FDA's approach on drug-drug interactions and personalized medicine(Material provided by Dr. Yuichi Sugiyama, a member of the Science Board)
- Document 2-1 Current situation and issues of personalized medicine(Material provided by Dr. Atsushi Ohtsu, a member of the Pharmaceuticals Subcommittee)
- Document 2-2 Current situation and issues of personalized medicine(modified version of the handout 2-1 for release)
- Document 3 Regulatory trend of personalized medicine and companion diagnostics
- Document 4 Ways to proceed to a discussion at the Pharmaceuticals Subcommittee and the Bio-products Subcommittee
- Document 5 Pharmacology study of anticancer pharmaceuticals
- Document 6 Proposed measures on pharmacology study of anticancer pharmaceuticals by the Pharmaceuticals & the Bio-products Subcommittees
- Ref.1 Targeted outcomes of the Subcommittees
- Ref.2 Partial amendment of the Pharmaceuticals Affairs Law