Since 1976, Tufts CSDD has provided robust, objective evidence-based research, analysis, and insight, which have informed stakeholders throughout the drug development enterprise. Here are select Tufts CSDD research milestones during our 46+ year history:

 
 
 
Drug lag
 
 
 
cost to develop new drug
 
 
 
patent life therapeutic compounds
 
 
 
orphan drug act
 
 
 
drug safety withdrawals
 
 
 
fda post-approval research
 
 
 
new drug cost study
 
 
 
biotechnology product discovery international
 
 
 
biotechnology success rates
 
 
 
FDAMA
 
 
 
FDA sponsor meetings new drug
 
 
 
PDUFA drug development times
 
 
 
FDAMA pediatric research incentive program
 
 
 
new drug biopharmaceutical approval times centralized procedure european medicines evaluation agency
 
 
 
cost pharmaceutical r&d develop new drug
 
 
 
FDA fast track program development times
 
 
 
follow-on drug development incremental innovation
 
 
 
drug safety withdrawals speed regulatory approval lack of correlation
 
 
 
cost develop new biotechnology product
 
 
 
outsourcing practice individual outsourcing models
 
 
 
oncology drug R&D approval success rate 8%
 
 
 
US drug plans 88% therapeutic non-compliant medicare regulations
 
 
 
new drug clinical success rates clinical success rates 16%
 
 
 
orphan drug development 25% new approvals
 
 
 
clinical useful diagnostics personalized medicines incidence protocol
 
 
 
protocol complexity
 
 
 
vaccine development trends
 
 
 
average cost pharmaceutical R&D
 
 
 
rapid growth pharmaceutical benefit managers exclusion lists drug developers
 
 
 
FDA 505 (b) (2) regulatory pathway review+process+molecular entity approvals
 
 
 
data volume data diversity clinical trials
 
 
 
patient engagement oncology development programs
 
 
 
real world evidence data artificial intelligence
 
 
 
volume cost vendor qualification re-qualification
 
 
 
participant demographic diversityp ivotal+trials+FDA+approved+drugs+biologics