1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma;Eichler;Nature Reviews Drug Discovery,2008
2. Dealing with global safety issues: was the response to QT-liability of non-cardiac drugs well coordinated;Stockbridge;Drug Safety,2013
3. Prescription Drug User Fee Act www.fda.gov http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm
4. ICH History www.ich.org http://www.ich.org/about/history.html