By Siva Reddy
While thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.
With global regulatory changes happening quickly and often, there is concern that sponsors need more robust systems to keep pace and have a global disclosure strategy in place.
CDRH announced its top 10 Regulatory Science Priorities for Fiscal Year 2016, and stated that these priorities are more than a mere philosophical statement of topics of interest; rather, these priorities are expected to influence CDRH intramural funding decisions.
The MHRA is seeking input on identifying new uses for an existing drug in another indication, or creating novel combinations and sees it as "an emerging and dynamic field of drug development."
The study authors surmised that the lack of validation studies of initial trial results reflected that one goal of open access is not being met. Further, they believe that the limited use indicates a “failure to get the word out “ to researchers.
Dr. Christa Wirthumer-Hoche has been elected as the new chair of the Management Board of the European Medicines Agency (EMA).