Another QMSR Town Hall – What Changes and What Stays the Same in FDA’s Inspection Process
The FDA held its April 1 QMSR town hall to clarify how inspections will change once the Quality Management System Regulation takes effect on February 2, 2026. Inspectors will evaluate every element of a manufacturer’s QMS, emphasizing risk‑management documentation throughout the system. While the core inspection steps—facility tour, Form 482, Form 483—remain, statistical sampling is dropped and record review will be risk‑based. New focus areas include management review, internal audits, and supplier audits, with culture of quality judged by everyday decisions rather than separate paperwork.
FDA Seeks Input on Digital Health Technologies in Clinical Investigations for Drugs and Biological Products
The FDA has issued a Federal Register notice seeking stakeholder input on the use of digital health technologies (DHTs) in clinical investigations for drugs and biologics. The agency asks for comments on regulatory challenges, guidance needs, and topics for future...