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
The human cost is measured in deaths. The financial cost is measured in the $52 billion taxpayers pay annually end stage renal disease – double NASA’s budget.
Gilman Louie, Longest Serving Board Chair of the Federation of American Scientists, Named Chair Emeritus
The proposed Office will resurrect the long-closed Office of Technology Assessment (OTA), the archive of which has been maintained by FAS for decades at https://ota.fas.org/.
If Congress needs help understanding the risks and rewards of a piece of technology, they shouldn’t have to rely solely on the sparknotes from a salesman. The rub is much simpler: Congress needs nerds.