Blogs

Oct 30, 2017
Applied Clinical Trials
Jill Wechsler talks about biosimilars and the requirement of clinical trials in her recent blog.
Oct 27, 2017
Applied Clinical Trials
As concerns grow about the slow progress of advanced therapies, drug developers are pushing for action from European authorities.
Oct 20, 2017
Applied Clinical Trials
Tensions mount across the European pharmaceutical scene over the fate of the EMA with just weeks before the final decision is going to be made on where it will be moved to.
Oct 13, 2017
Applied Clinical Trials
FDA advisory committee made up of patients comes together to improve clinical trials and product development through better study design and greater participation.
Oct 10, 2017
Applied Clinical Trials
Most physicians and many specialists have limited understanding of clinical trial data and research findings presented in prescription drug promotional materials for professional audiences.
Oct 06, 2017
Applied Clinical Trials
The Duke Margolis Center for Health Policy (DMCHP) recently collaborated with the FDA to release an mHealth action plan entitled "Mobilizing mHealth Innovation for Real-World Evidence Generation."
Oct 05, 2017
Applied Clinical Trials
This article will dive into the details of FDA’s movement in mHealth, analyze FDA’s approach, and assess how this movement impacts the use of mHealth in clinical trial settings.
Sep 26, 2017
Applied Clinical Trials
Gaps in the good manufacturing practice controls on medicines for clinical trials are targeted in new rules from the EU.
Sep 26, 2017
Applied Clinical Trials
The EMA isn't mincing its words about the challenge it faces with the relocation that will be forced on it by Brexit. It has been stated that "the future of public health in Europe is at stake" and this decision will make or break it.
Sep 26, 2017
Applied Clinical Trials
There is a critical need to rethink standards of evidence and of the reliability of information used to make regulatory decisions. According to the FDA, this involves placing greater reliance on data from sources outside traditional clinical studies and because of these new tools for collecting the data, the FDA needs to adapt as well.
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