This year marks the 150th anniversary of the USDA and the 40th of APHIS (Animal and Plant Health Inspection Service). A successor of the Bureau of Plant Industry in 1972,…
FDA recently held a public webinar to discuss its draft guidance recommending targeted safety data collection in certain drug trials. The presentation and slides are now available on FDA’s website. According…
On March 29th, NIH and Amazon Web Services jointly announced the public availability of the 1000 Genomes data set, which will ultimately include data from over 2600 samples and is being…
The US government recently released a document entitled, “United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern“, available on the NIH Office of Biotechnology Activities…
Healthcare professionals are sold on the clinical benefits of health IT tools such as clinical decision support, e-prescribing, telemedicine and electronic health records (EHRs) – when they work well and…
Implanted medical devices would require unique numerical identifiers under new legislation proposed by a group of US senators. A UDI program created almost 5 years ago has yet to be…
According to a survey conducted in December 2011 by Clinical Research Site Training, conflicts with clinical practice are the primary reason investigators stop conducting research studies. Unprofitable trials are another…
Tempting as it might be to think of tuberculosis (TB) as a disease of history, the World Health Organization estimates that 1.45 million people died of TB in 2010. Up…
Does noncompliance by clinical trial participants put future patients at risk? The Consumer Health Information Corporation says there might be a link between participant nonadherence and postmarketing safety issues. According…