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.
India’s Central Drugs Standard Control Organization has a released a draft document outlining accreditation and ethics standards for clinical trial sites, investigators and ethics committees. Read More
Sponsors of clinical trials comparing two or more standards of care should ensure that potential enrollees understand the pros and cons associated with each of the treatment options, HHS' Office of Human Research Protections says. Read More
India’s Central Drugs Standard Control Organization is seeking industry feedback on a draft of accreditation and ethics standards that it expects from clinical trial sites, investigators and ethics committees. Read More
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
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.
A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. Read More