Systems Biology Opens New Research Pathways
Systems Biologists Are Attacking the Encrypted Messages That Would Allow Us to Predict and Change the Course of Disease
Individual Tumor Profiling
Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?
Top 10 Under 40
Up-and-Coming Stars Shine in Biopharma Research and Business
Podcast: FDA’s New Commissioner Hits the Ground Running
Scott Gottlieb, M.D., Commits to Speeding Up Drug Reviews, and Maintaining Safety and Efficacy
Quicker Development and Investing
Congress appears poised this year to deliver on years of lobbying by industry to speed up reviews of new drugs and cut regulatory red tape. Chief among several related bills is the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Faster action on drug applications is the goal of the Faster Access to Specialized Treatments (FAST) Act introduced in the House of Representatives, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act introduced in the Senate, and another Senate bill, the Advancing Breakthrough Therapies for Patients Act of 2012. The impact of these legislations would be seen in the Phase II and III stage and less so in the valley of death.