RAPS

Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers

A new framework that rethinks the corrective and preventive action (CAPA) process by using a risk-based approach has been given the thumbs-up by the US Food and Drug Administration (FDA), with one ...
RAPS

FDA cites Amazon and others for selling unapproved drugs, drugmakers for CGMP violations

The US Food and Drug Administration (FDA) has cited several online companies, including retail giant Amazon, for selling products that have not been evaluated for safety and efficacy by regulators. It ...