With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner. Concurrently, the US Senate is working to permanently...
The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill...
Uk.reuters.com just released an article about the lackluster number of approved drugs by FDA in 2013. In 2013 only 27 were approved vs. 39 in 2012, which was the most since 1997. FDA attributed the large decrease to fewer applications in 2013 which was down from 41 to...
On September 10, 2013, the Tufts Center for the Study of Drug Development released a report concerning the leading causes of failures in drug development. Based on a study of products that entered clinical development from 2000 through 2009, the study found that Phase...
The healthcare industry, medical research and drug approval process are projected to be greatly affected by the federal budget cuts scheduled for March 1, according to a recent article on mondernhealthcare.com. The Budget Control Act of 2011, originally scheduled to...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?