Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.

Manufacturers seek real-world benefits from investment in QbD and risk-management strategies. This article contains bonus online-exclusive material.

FDA is taking several measures to ensure that imported drugs meet manufacturing standards.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.

New scientific discoveries promise to expand treatments for rare and neglected diseases.

Comparative-effectiveness analysis aims to promote appropriate pharmaceutical spending.

Regulators face demands to improve postmarket surveillance and meet review deadlines.

Heparin contamination casts a shadow on regulatory oversight of product quality.

Quality-by-design submissions may reduce supplements and improve change management.