Additional Resources
FDA Resources: Safety Labeling:
- FDA Data on PDUFA Drug Approvals, Safety Withdrawals and New Boxed Warnings
- Guidance for Industry - Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling and Biological Products -- Content and Format
- Approved Risk Evaluation and Mitigation Strategies (REMS)
- Patient Medication Guides for Selected Drugs with Black Box Warning