Revised Compliance Guides for PAIs and GMP Drug Inspections, New Guidances On Device Post-Approval Studies, Postmarket Surveillance + Warning Letter Breakdown

Welcome to Insider issue #10.

And welcome to the 152 new life science professionals who joined last month.

Today we’re picking apart two compliance policy guides (CPGs) FDA recently revised and how RA/QA teams in the drug space may want to react to those revisions. One CPG covers preapproval inspections (PAIs). The other covers routine good manufacturing practice (GMP) drug inspections.

On the device side, we’re diving into two final guidances FDA recently issued to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket surveillance requirements and better understand the agency’s expectations for conducting post-approval studies of these products.

Lastly, we’re dissecting a recent Warning Letter to a US sterile injectable maker on contamination controls.