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 Scottish Medicines Consortium plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More