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.

The rise in overseas manufacturing undermines FDA oversight of drug quality.

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.