Blog
FDA emphasizes the crucial role of IRBs in new draft guidelines
The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the clinical research process. The new guidance, issued in November 2012 entitled “IRB...
Dont miss the FDLI enforcement, litigation, and compliance conference!
The Food and Drug Law Institute annual conference will be held on December 12-13, 2012 in Washington, DC. The two- day conference welcomes attorneys, litigators, regulators, compliance experts, consultants, and academics in the drug, medical devices, biologics, food...
NCI receives enthusiastic feedback from recent pilot study
Huron Life Sciences recently released an article about a recent pilot study conducted by National Cancer Institute (NCI). During the month of October, The NCI conducted a pilot study testing feasibility of using an independent CIRB model. Twenty- four institutions...
Save the date- March 4-5, 2013, IHIF is holding annual conference
The Indiana Health Industry Forum annual conference will be held on March 4-5, 2013 at The Alexander Hotel in Indianapolis, Indiana. Come ready for all events as there will be opportunities to network and see new views on the progress and growth of Indiana’s health...
Supplementary data research causing unnecessary expenditures
Ken Getz, assistant professor at Tufts Center for the Study of Drug Development (CSDD), reports that oftentimes procedures performed in the last drug development stages are in order to find "supplementary, secondary, tertiary, and exploratory endpoints." (Carroll) On...