Artful Approach Improves NDI Notifications’ Chances At FDA
This article was originally published in The Tan Sheet
FDA accepts only 25% of NDI notifications on first submission, but firms can improve their chances by organizing notifications in easy-to-read narratives, suggests attorney Ashish Talati. Hiring independent toxicologists to review safety also can boost a firm’s chance at success.
You may also be interested in...
Early and frequent communication with FDA is key to earning an elusive FDA acceptance of a new dietary ingredient notification on the first try, an agriculture-tech firm executive says
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.