Briefs

QHub Brief║Drug-Device Combination Products & QMSR Compliance: FDA Expectations for Device Constituent Parts

May 7, 2026

In this QualityHub Brief, pharma companies are introduced to the unique regulatory and manufacturing challenges associated with developing combination products, even when using standard delivery

QHub Brief║Interpreting FDA’s QMSR Compliance Program: FDA Inspection Types & Corresponding Models

March 6, 2026

With the FDA’s regulatory change from QSR to QMSR for medical devices comes an update of the agency’s Compliance Program Manual (CPM) for the inspection