ARTICLE

FDA's Enhanced Oversight and Compliance Measures

The FDA has ramped up its enforcement of Good Manufacturing Practices (GMP) across the pharmaceutical supply chain, particularly targeting contract manufacturing oversight. In 2026, approximately 35% of warning letters issued cited cGMP...

REGULATORY · FDA

Implementation of Quality Management System Regulation (QMSR)

Effective February 2, 2026, the FDA implemented the QMSR to align device CGMP with ISO 13485:2016, impacting finished medical device manufacturers.

REGULATORY · FDA

First Public DSCSA Form 483 Observation Issued

In February 2026, the FDA issued its first public DSCSA Form 483 observation to a dispenser, reinforcing the enforcement of baseline obligations under the Drug Supply Chain Security...

REGULATORY · FDA

Warning Letter Highlights Laboratory Deficiencies

A Warning Letter dated February 12, 2026, cited a Lynden, Washington manufacturer for systemic laboratory quality control failures, including absent microbiological testing specifications.

MANUFACTURING · FDA

GDUFA III Requirements for API Provenance Certification

Starting FY2026, GDUFA III mandates API provenance certification and imposes penalties for delays in outsourced testing, emphasizing the importance of supply chain integrity.

MANUFACTURING · FDA

New Compliance Program for Medical Devices

The FDA has discontinued the Quality System Inspection Technique, adopting a revised Compliance Program 7382.850 aligned with the new QMSR, enhancing inspection protocols for medical devices.

MANUFACTURING · FDA

CDER Guidance Agenda for Supply Chain Security

The CDER's February 2026 Guidance Agenda focuses on supply chain security and revisions to CGMP for PET drugs, addressing critical areas in pharmaceutical manufacturing.