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 number of clinical trials in India is rebounding after plunging precipitously in recent years following the government’s imposition of strict new regulations on the clinical trial industry. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More
The FDA and India’s Ministry of Health and Family Welfare signed a five-year accord that will allow them to share information from clinical trial inspections in their respective jurisdictions. 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
Vaccine trial sponsors should report study-related fatalities within seven days of an event and submit follow-up reports by eight days later, a recent China Food and Drug Administration guideline says. 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