Quality metrics are being developed by the US FDA to not only determine which medical device facilities to inspect next, but to also raise firms' overall approach to quality above baseline. In-process metrics work by the Medical Device Innovation Consortium will be used as the agency comes up with its own robust set of measurements. Meanwhile, FDA is gearing up for a new pilot program targeting 10-20 device manufacturers that will submit quality data to the agency; MDIC explains how to calculate its three quality metrics; and quality officials from Baxter, J&J and Stryker weigh in.

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.