In addition to the Senate bill, the U.S. Food and Drug Administration (FDA) announced regulations in mid-June that would streamline the process for making generic drugs available to consumers.
Congress focused on Medicare reform in June, with both the House and Senate passing their own versions of a Medicare prescription drug program.
As the scrutiny and duties of IRBs steadily increase, demanding ever more time from IRB members, it has become clear to some research universities and hospitals that there should be a change in whether and how IRB members are compensated for their time.
In this issue of IRB Advisor, we are starting a new column designed to answer reader questions. If you have questions regarding IRB responsibilities, federal regulations, adverse event reporting, day- to-day functions, anything related to clarifying the duties and responsibilities of your IRB, wed like to know.
Current federal research regulations in the United States limit efforts to study emerging infectious diseases, and an alternative model is needed to allow a rapid response to immediate threats to public safety, a top U.S. researcher claims.