ARTICLE

FDA's Enhanced Enforcement: A 2026 Priority

The FDA has ramped up its enforcement actions across the pharmaceutical supply chain, with a particular focus on Good Manufacturing Practices (GMP). In 2026, the agency warned that it will scrutinize contract...

REGULATORY · FDA

GDUFA III Implementation

Effective FY2026, GDUFA III mandates sponsors to certify the provenance of Active Pharmaceutical Ingredients (APIs) and imposes penalties for delays in outsourced testing.

REGULATORY · FDA

DSCSA Enforcement Initiatives

The FDA's enforcement of the Drug Supply Chain Security Act (DSCSA) targets pharmacies' ability to verify package sources and track products from manufacturers to patients.

REGULATORY · FDA

New QMSR Regulations

As of February 2, 2026, the Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 into 21 CFR Part 820 for medical devices.

MANUFACTURING · FDA

Increased GMP Inspections

The FDA's inspections in March 2026 focused on sampling practices, emphasizing the need for documented supplier qualifications.

MANUFACTURING · FDA

Form 483 Issued for DSCSA Violations

The FDA issued its first public Form 483 to a dispenser in 2026, marking a significant step in enforcing DSCSA obligations.

MANUFACTURING · FDA

Contract Manufacturing Oversight

The FDA emphasizes the importance of contract quality agreements that specify data sharing and audit rights, especially in light of increased enforcement actions.