The procedures by which the Food and Drug Administration approves drugs and medical devices for use in the United States were addressed in a cluster of reports from the Congressional Research Service.
How FDA Approves Drugs and Regulates Their Safety and Effectiveness, June 25, 2012
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, June 25, 2012
FDA Regulation of Medical Devices, June 25, 2012
The FDA Medical Device User Fee Program, June 25, 2012
No one will be surprised if we end up with a continuing resolution to push our shutdown deadline out past the midterms, so the real question is what else will they get done this summer?
Rebuilding public participation starts with something simple — treating the public not as a problem to manage, but as a source of ingenuity government cannot function without.
If the government wants a system of learning and adaptation that improves results in real time, it has to treat translation, utilization, and adaptation as core functions of governance rather than as afterthoughts.
Coordination among federal science agencies is essential to ensure government-wide alignment on R&D investment priorities. However, the federal R&D enterprise suffers from egregious siloization.