Causation Disclaimers Should Be In Adverse Event Reports Submitted To FDA
This article was originally published in The Tan Sheet
Dietary supplement firms should use a script for receiving AERs and establish review protocols to ensure serious events are reported to FDA, recommends attorney Claudia Lewis. She detailed best practices for supplement AERs at a recent American Conference Institute conference.
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Serious AERs submitted to FDA have plateaued since 2010, though reports the agency receives from consumers steadily increased. While FDA suspects supplement firms are not providing all serious AERs as required, stakeholders say the agency overestimates the number of serious AERs.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.
GlaxoSmithKline restructures its management to ensure adequate focus on its three core areas, pharmaceutical, vaccine and consumer. Consumer product sales fell 3% to $1.72 billion in the third quarter due to continuing supply interruptions and generally weaker markets.