“Black box” 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk

Safety of Long-Acting β-Agonists: Are New Data Really Required?

Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials

Novel Therapies, High-Risk Pediatric Research, and the Prospect of Benefit: Learning from the Ethical Disagreements

Old Drugs, New Concerns

Treatment of Obesity

A Unifying Ontology to Integrate Histological and Clinical Observations for Drug-Induced Liver Injury

“Black box” warning: Wake-up call or overreaction?

Reporting standards for adverse events after medical device use in the peripheral vascular system

Report of the Topical Calcineurin Inhibitor Task Force of the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology

Statins in the Treatment of Dyslipidemia in the Presence of Elevated Liver Aminotransferase Levels: A Therapeutic Dilemma

8. Drug allergy

Controlled-release opioids cause harm and should be avoided in management of postoperative pain in opioid naïve patients

Fever, Rash, and Systemic Symptoms: Understanding the Role of Virus and HLA in Severe Cutaneous Drug Allergy

The Impact of Testosterone Therapy in Men on Cardiovascular Risk: Don’t Be Too Quick to Condemn

Drug-Induced Liver Injury, Dosage, and Drug Disposition: Is Idiosyncrasy Really Unpredictable?