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
We came out of the longest shutdown in history and we are all worse for it. Who won the shutdown fight? It doesn’t matter – Americans lost. And there is a chance we run it all back again in a few short months.
Promising examples of progress are emerging from the Boston metropolitan area that show the power of partnership between researchers, government officials, practitioners, and community-based organizations.
Americans trade stocks instantly, but spend 13 hours on tax forms. They send cash by text, but wait weeks for IRS responses. The nation’s revenue collector ranks dead last in citizen satisfaction. The problem isn’t just paperwork — it’s how the government builds.
In a new report, we begin to address these fundamental implementation questions based on discussions with over 80 individuals – from senior political staff to individual project managers – involved in the execution of major clean energy programs through the Department of Energy (DOE).