The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA is working on a number of projects designed to lower clinical trial costs and speed up trial times, a top FDA official told conference-goers at the Society for Clinical Research Sites’ 2014 Site Solutions Summit. Read More
Drug sponsors need to find more thoughtful, comprehensive ways of recording and integrating patient outcomes data into their efficacy analyses, but long questionnaires may not be the solution, a top FDA official says.
Drug sponsors conducting a clinical trial should take efforts to better understand the effects of a particular disease on patients when designing ways to measure patient-reported outcomes, says an FDA clinical trials official. Read More
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions. Read More
An article published in last month’s Journal of the American Medical Association is casting doubt on the idea that the scientific community and the general public should trust clinical trial results. Read More
Local and regional medicines authorities need to have mechanisms in place to ensure that clinical trial data quality is preserved in secondary studies, a Washington, D.C.-based think tank says. Read More
Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Aug. 20. Read More