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.
Congress should strengthen the FDA’s authority to request and enforce postmarket surveillance of drugs and biologics whose approvals are initially based on surrogate endpoints, according to a new report from the Institute of Medicine (IOM). Requested by the FDA, the report also suggests that HHS launch a departmentwide effort to encourage the collection and sharing of biomarker data. The FDA should use the same degree of scientific rigor to evaluate biomarkers used for drug clinical trial endpoints as it does for biologics or other regulatory areas, the report says. Washington Drug Letter