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What’s Hot in the Regulatory World

What’s Hot in the Regulatory World

By Richard D’Alosio, EAS Independent Consultant I have always described working in regulatory as an iceberg, with the obvious black and white answers to inquiries akin to the visible iceberg floating in the water. However, underneath the water is the unknown or...
Labeling Risk Management – Five Step Plan

Labeling Risk Management – Five Step Plan

By Ronald J. Levine Food labels are under attack. Every day new lawsuits are filed, often as class actions, as well as through regulatory actions. Legal actions concerning words such as “natural,” or “healthy” are all too common. THE FIVE STAGES OF GRIEF While some of...
Adverse Event Reporting for OTC Drug Products

Adverse Event Reporting for OTC Drug Products

By EAS Senior Advisor for OTC Drugs and Labeling Susan Crane The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by...