Major announcements from the National Institutes of Health and Food and Drug Administration bode well for accelerating the development and approval of new drugs as clinical therapies. The National Institutes of Health (NIH) Scientific Management Review Board has voted to establish a National Center for Advancing Translational Sciences. The role of this proposed new center would be to establish a focused, integrated, and systematic approach to link basic science research with therapeutics development and clinical care. This has been a missing bridge at the NIH, so this announcement is being very well received. More.
The Food and Drug Administration, meanwhile, have announced the intention to accelerate drug approvals, issuing new draft guidelines aimed at speeding development work by encouraging joint applications for two drugs simultaneously. Currently, drugs must be approved singly and if joint use is proposed this use must then be separately approved. “We expect increasing use of combinations,” noted Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This isn’t just true of cancer. It’s going to be true of many serious diseases.” More.
