Inspections and Audits

Hamburg: Global Regulatory Authority in the Works

To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities (ICMRA), Commissioner Margaret Hamburg says. Read More

ISPE Launches Quality Metrics Pilot Program

The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More